comparison between betamethasone gel, lidocaine jelly

i

“COMPARISON BETWEEN BETAMETHASONE GEL, LIDOCAINE JELLY

AND LUBRICATING JELLY APPLIED OVER ENDOTRACHEAL TUBE TO

REDUCE POST OPERATIVE SORE THROAT, COUGH AND HOARSENESS

OF VOICE”

BY

Dr. SRINIVASA .B M.B.B.S.

Dissertation submitted to the

Rajiv Gandhi University of Health Sciences, Karnataka Bangalore.

In partial fulfillment of the requirements for the degree of

DOCTOR OF MEDICINE

IN

ANAESTHESIOLOGY

Under the guidance of

Dr. Prasad Kulkarni MD

Professor

DEPARTMENT OF ANAESTHESIOLOGY

MVJ Medical College & Research Hospital

Hoskote, Bangalore: 562114

2016

iii

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA.

DECLARATION BY THE CANDIDATE

I hereby declare that this dissertation entitled “COMPARISON BETWEEN

BETAMETHASONE GEL, LIDOCAINE JELLY AND LUBRICATING JELLY

APPLIED OVER ENDOTRACHEAL TUBE TO REDUCE POST OPERATIVE SORE

THROAT, COUGH AND HOARSENESS OF VOICE” is a bonafide and genuine

research work carried out by me under the guidance of Dr. Prasad Kulkarni, Professor,

Department of Anaesthesiology, MVJ Medical College & Research Hospital Hoskote-

Bangalore.

Dr. SRINIVASA . B

Date: Postgraduate in Anaesthesiology

Place: Bangalore MVJ Medical College & Research Hospital

Hoskote, Bangalore.

v


KARNATAKA.

CERTIFICATE BY THE GUIDE

This is to certify that the dissertation entitled “COMPARISON BETWEEN



THROAT, COUGH AND HOARSENESS OF VOICE” is a bonafide research work done

by Dr. Srinivasa. B in partial fulfillment for the requirement for the degree of M.D.

(Anaesthesiology)

Date:

Signature of the Guide

Place: Bangalore

Dr. Prasad Kulkarni, MD

Professor

Department Of Anaesthesiology

MVJ Medical College &Research

Hospital Bangalore.

vii


KARNATAKA.

ENDORSEMENT BY THE HOD/PRINCIPAL/HEAD OF THE INSTITUTION

This is to certify that this dissertation entitled “COMPARISON BETWEEN



THROAT, COUGH AND HOARSENESS OF VOICE” is a bonafide research work done

by Dr. Srinivasa .B under the guidance of Dr. Prasad Kulkarni, Professor, Department of

Anaesthesiology, MVJ Medical College & Research Hospital, Hoskote-Bangalore.

Signature of the Professor & HOD Signature of the Principal

Dr.A.V Pai Dr. T.S. RAGHURAMAN

Lt.Colonel (Retd) Air Vice Marshall (Retd.)

Professor & HOD Professor & Principal

Department of Anaesthesiology MVJ Medical College &

MVJ Medical College & Research Hospital Research Hospital

Hoskote, Bangalore. Bangalore.

Place: Bangalore Place: Bangalore

Date: Date:

viii


KARNATAKA.

COPYRIGHT

DECLARATION BY THE CANDIDATE

I hereby declare that the Rajiv Gandhi University of Health Sciences, Karnataka,

Bangalore, shall have the rights to preserve, use and disseminate this dissertation in print or

electronic format for academic/research purpose.

Date: Dr. SRINIVASA. B Place: Bangalore Postgraduate in Anaesthesiology,

MVJ Medical College & Research Hospital

Hoskote, Bangalore.

© Rajiv Gandhi University of Health Sciences, Karnataka

ix

ACKNOWLEDGEMENT

Presenting with this dissertation, I take this opportunity to acknowledge the guidance I

received from all quarters.

At the outset, I express my deep sense of gratitude and indebtedness to my most

respected guide and teacher Dr.Prasad Kulkarni, M.D., Professor, Department of

Anaesthesiology, MVJ Medical College & Research Hospital, Hoskote- Bangalore., for his

constant help, valuable advice and able guidance throughout the study. His ever-willing

keenness to help and guide was a constant source of inspiration to me.

I am extremely grateful and indebted to Dr. A.V.Pai, Professor and Head, Department

of Anaesthesiology, M.V.J. Medical College and Research Hospital, for infusing zeal and

giving priceless guidance enabling me to complete this venture.

I owe a great sense of indebtedness to Dr. T.S. Raghuraman, Principal, M. V. J.

Medical College and Research Hospital, Hoskote, who has been a constant source of

inspiration all the time during my post graduate course and permitting me to use the hospital

resources in doing this study.

It gives me immense pleasure to express my sincere thanks to my professors

Dr.Somashekaram P, Dr.B.N.Reddy, Dr.Susheelashekhar for their valuable scholarly

suggestions and constant help.

I express my sincere thanks to Dr.Nirmala B.C., Associate professor, and all asst.

professors for their words of encouragement and constant help.

In a special mention, I am indebted to all my seniors whose constant supervision,

praises, criticism and assistance have marked my formative years in anaesthesiology with

memories to cherish.

I owe my thanks to my colleagues and technical staff of the department for the help

extended.

I specially thank my parents, my wife Dr.Uma.U.G for their support and for being my

source of inspiration throughout.

Last but not the least; I thank all the patients who have subjected themselves to this

study, as without their cooperation this dissertation would not have been completed.

Dr.Srinivasa.B, M.B.B.S.

x

LIST OF ABBREVIATIONS

ASA – American Society of Anaesthesiologists

ASTM - American Society for Testing and Materials

DLT - Double Lumen Tube

ETT – Endotracheal tube

IV - Intravenous

IPPV - Intermittent Positive Pressure Ventilation

LMA - Laryngeal Mask Airway

Mcg - microgram

NRS - Numerical Rating Scale

PVC - Polyvinyl chloride

PLMA - Proseal Laryngeal Mask Airway

SPSS - Statistical Package for Social Services

TOF - Train of Four

VAS - Visual Analogue Scale

xi

ABSTRACT

BACKGROUND

The control and protection of airway is important in general anesthesia. The patients who are

intubated experience many short term and long term complications and airway injury. The

airway trauma, physiological reflexes like tachycardia and hypertension, malposition,

laryngospasm, narrowing and increased airway resistance and negative pressure pulmonary

oedema are complications experienced by the patients with intubation. Post-operative sore

throat, cough and hoarseness of the voice are common uncomfortable sequelae of the tracheal

intubation. A number of pharmacological and non-pharmacological measures are often used for

alleviating the post-operative sore throat, cough and hoarseness of voice with varying degree of

success. Betamethasone gel, Lidocaine jelly and water based Water based lubricating jelly are

also tried by many researchers with varying success.

OBJECTIVES

This study was undertaken to compare the efficacy of Betamethasone gel, Lidocaine jelly

and water based lubricating jelly as lubricants in reducing post-operative sore throat, cough and

hoarseness of voice in patients operated under general anaesthesia with orotracheal intubation.

MATERIALS AND METHODS

A randomized controlled study was undertaken among the patients posted for elective

surgeries under general anesthesia with orotracheal intubation at MVJ medical college and

research hospital, Bengaluru. One hundred and fifty three patients were divided into three

groups. First group was treated with Betamethasone gel, second group treated with Lidocaine

jelly and third group was treated with Water based lubricating jelly. The patients were assessed

xii

for post-operative sore throat, cough and hoarseness of voice at 1, 6, 12 and 24 hours after

extubation by the anaesthetist using questionnaire.

RESULTS

The age and sex was comparable between the three groups. 31.4% of the patients in

Betamethasone gel group had moderate sore throat and 2% had severe sore throat at 1 hour, in

Lidocaine Jelly group, 52% had moderate sore throat and 14% had severe sore throat. In

Lubrication jelly group only 1.9% of the subjects had moderate sore throat. At the end of 24

hours, 7.8% had minimal sore throat in Betamethasone gel group, 20% in Lidocaine Jelly

group had minimal, moderate and severe sore throat put together. At the end of 1 hour 31.4%

in Betamethasone gel group had minimal cough and 23.5% had moderate cough, In Lidocaine

Jelly group, 18% had minimal cough, 38% had moderate cough and 8% had severe cough. In

water based lubricating jelly group, 5.8% had minimal cough. At the end of 24 hours, 2% had

minimal and 2% had moderate cough in Betamethasone gel group. In Lidocaine Jelly group,

6% had minimal cough, 8% had moderate cough and 2% had severe cough. In Lubricating gel

group, none of the patients had cough. At the end of 1 hour,39.2% had no evidence of

hoarseness,27.5% had evidence of hoarseness at the time of interview in Betamethasone gel

group. In Lidocaine Jelly jelly group 10% had no evidence of hoarseness,36% had evidence of

hoarseness at the time of interview. In Water based lubricating jelly group 25% had no evidence

of hoarseness, 3.8% had evidence of hoarseness at the time of interview. At the end of 24

hours, 3.9% had no evidence of hoarseness and 5.9% had hoarseness easily noted at the time of

interview in Betamethasone gel group. In Lidocaine Jelly group, 2% had no evidence of

hoarseness, 2% had hoarseness at the time of interview and 2% had hoarseness easily noted at

the time of interview. In Water based lubricating jelly group, 5.8% had no evidence of

hoarseness at the time of interview at the end of 24 hours.

xiii

CONCLUSION

The study has shown that water based lubricating jelly when applied over endotracheal tube

during endotracheal intubation has low incidence of post-operative sore throat, cough and

hoarseness of voice compared to Betamethasone gel and Lidocaine jelly.

Keywords: Endotracheal intubation, post-operative sore throat, cough, hoarseness of voice,

Betamethasone gel, Lidocaine jelly, Water based lubricating jelly.

xiv

TABLE OF CONTENTS

SI.No TOPIC PAGE No.

1 Introduction 1

2 Aims & objectives 4

3 Review of Literature 5

4

Pharmacology: (a) Betamethasone gel (b) Lidocaine Jelly (c) Water based Lubricating (Lubic) jelly

26 29 33

5 Materials and Methods 35

6 Results 39

7

Discussion

58

8 Conclusion 70

9 Summary 71

10 Bibliography 75

Annexures 83

Consent Form

11 Master Chart

xv

LIST OF FIGURES

SI.No Figures Page No.

1 The external view of the Larynx 6

2 Sagittal section of the Larynx

7

3 Cartilages of the Larynx

7

4 ETT made of different materials

11

5 ETT with cuff made from polyvinyl chloride

11

6 Insertion of Endotracheal tube 14

7 Betamethasone gel 0.05% 28

8 Lidocaine jelly 2% 32

9 Lubic jelly 34

xvi

LIST OF CHARTS

1 Distribution of the study group according to age group 39

2 Distribution of study group according to sex 40

3 Distribution of study group according to ASA grade 41

4 Distribution of study group according to sore throat at 1 hour 42

5 Distribution of study group according to sore throat at 6 hours 43



8 Distribution of study group according to cough at 1 hour 46

9 Distribution of study group according to cough at 6 hours 47



12 Distribution of study group according to hoarseness at 1 hour 51

13 Distribution of study group according to hoarseness at 6 hours 53



xvii

LIST OF TABLES

1 Distribution of the study group according to age group 39

2 Distribution of study group according to sex 40

3 Distribution of study group according to ASA grade 41

4 Distribution of study group according to sore throat at 1 hour 42




8 Distribution of study group according to cough at 1 hour 46




12 Distribution of study group according to hoarseness at 1 hour 50




1

INTRODUCTION

General anaesthesia is commonly performed procedure in Anaesthesiology practice.

The management of the airway during the anaesthesia is an important task of the

anaesthesiologist during the delivery of general anaesthesia. The artificial maintenance of

airway is the essence of the maintenance of the airway since anesthetized patients are unable

to maintain an adequate airway voluntarily.1

The control and protection of airway is often established during general anaesthesia

by endotracheal intubation. It also has many advantages including the provision of the

reliable airway, prevention of aspiration and smooth delivery of the anaesthetic gases. But, all

the patients who were intubated for long term or short term operations, experience some

degrees of airway injury. The injury may be during insertion, after insertion and during

extubation. The usual complications of the airway include airway trauma, physiological

reflexes like hypoxia, tachycardia and hypertension, malposition, larygospasm, narrowing

and increased airway resistance as well as negative pressure pulmonary oedema.2

Larynx is one of the most common sites of the injury which is manifested as local

irritation, inflammation and even necrosis. Majority of the injuries of the larynx are usually

minor and reversible. The oedema and granuloma formation, injury to the trachea after

extubation may manifest as acute or chronic obstruction of the airway which may be severe

enough for surgical intervention. These injuries can also impair the normal function of the

larynx and its protective roles and predispose the patient to pulmonary aspiration.3

Post-operative sore throat, cough and hoarseness of the voice are often common,

uncomfortable sequelae after tracheal intubation. The prevalence of these complications were

reported to be around 21% - 65% as per the literature available.4 The incidence of sore throat

during the placement (insertion) of the laryngeal mask airway is reported to be 34% - 58%.

2

Even though these complications are minor they contribute significantly to the post-operative

morbidity and patient dissatisfaction and may decrease the patient satisfaction with their

anaesthetic and surgical experience.5, 6

A number of factors are known to result in sore throat like irritation and inflammation

of the airway, trauma to the pharyngolaryngeal mucosa, cuff design, contact of the tracheal

tube with vocal cords, cuff form, pressure induced tracheal mucosal capillary hypo perfusion

and pressure over the posterior pharyngeal wall resulting in oedema and mucosal lesions.

Along with these factors sex, age, season, anaesthetic drugs and gases, number of trials of

intubation and duration of intubation also known to correlate with sore throat, cough and

hoarseness of voice7, 8, 9

A number of pharmacological and non-pharmacological measures are often used for

alleviating the postoperative sore throat, cough and hoarseness of voice with varying degree

of success. The small sized endotracheal tubes, lubricating the endotracheal tubes with water

soluble jelly, careful airway instrumentation, intubation after full relaxation, minimizing the

intracuff pressure, gentle oropharyngeal suctioning and extubation when the tracheal tube

cuff is fully deflated are some non-pharmacological measures followed to prevent these

complications.10, 11

The pharmacological measures including Aspirin gargles, gargling with

azulenesulphonate and beclomethasone inhalation have been tried as per the literature

available.12, 13

The local anaesthetic agents such as Lidocaine jelly or spray are known to be

ineffective in preventing the sore throat after endotracheal intubation.6, 14

These agents are

known to limit the injury to the tracheal mucosa and prevent cough, they cannot be effective

in preventing sore throat since they lack anti-inflammatory effects.6The studies have also

3

proven that the application of local anaesthetic jelly limits potential damage to the tracheal

mucosa due to its lubricating properties which supresses the bucking on the tracheal tube.15

The literature has shown that the Betamethasone gel applied over the endotracheal

tube reduces the incidence of post-operative sore throat, cough and hoarseness of voice due to

its anti-inflammatory effect.16

The studies available have shown inconsistent results to prevent sore throat, cough

and hoarseness of the voice across the world and India. Hence, this study was undertaken in

order to establish the safety, efficacy and outcome of application of Betamethasone gel,

Lidocaine jelly and water based Lubricating jelly applied extensively over the endotracheal

tube in reducing these complications during the first 24 post-operative hours after elective

surgical procedures in patients under general anaesthesia with endotracheal intubation in an

anaesthetic setting of a tertiary care hospital.

4

AIM AND OBJECTIVES

Objectives of the study:

To compare the efficacy of Betamethasone gel, Lidocaine jelly and Water based

lubricating jelly as lubricants in reducing post-operative sore throat, cough and

hoarseness of voice in patients operated under general anaesthesia with

orotracheal intubation.

5

REVIEW OF LITERATURE

The airway management during general anaesthesia is often a crucial step in the field

of anaesthesiology. The main aim of the endotracheal tube management is assurance of the

gas exchange and prevention of aspiration. The adverse events occasionally occur in spite of

due care.

HISTORICAL PERSPECTIVES17, 18, 19

Intubation from the neck through a tracheostomy wound was performed in 1858 by

John Snow in anaesthetized animals. In 1858, Eugene Bouchut a paediatrician from Paris

developed a new technique for non surgical orotracheal intubation to bypass the laryngeal

obstruction resulting from a diphtheria related pseudomembrane. The tracheal tube insertion

in to the trachea in human beings was first ever described by Friedrich Trendlenberg in 1871.

This tube had a small, thick walled, low volume inflatable rubber cuff. In 1880, William Mc

Ewe from Glasgow, who was a surgeon by profession described the use of endotracheal tube

(ETT) passed blindly into the trachea through the mouth to relieve airway obstruction and for

anaesthesia. Guedel and Waters, in 1928, described a cuffed tracheal tube designed for closed

circuit intra-tracheal administration of anaesthesia using a carbon dioxide absorption

technique. This tube was similar to the Dorrance tube. It had a thin rubber cuff cemented to

the tube. When deflated the rubber cuff lay in folds close to the catheter wall. These tubes

showed effectiveness in preventing aspiration and sealing the trachea. Macintosh described a

tube which had self-inflating cuff designed by Mushin. This cuff facilitated controlled

ventilation for thoracic anaesthesia. Holes were cut in the tube underneath the cuff, the cuff

thus inflated only in inspiration.

6

ANATOMY AND PHYSIOLOGY OF THE LARYNX20

The human Pharynx consists of three compartments: the nasopharynx, the oropharynx

and the hypopharynx. The hypopharynx starts from the epiglottis and ends at the lower end of

the cricoid cartilage. The human larynx is a complex organ which functions at the junction of

the digestive tract and respiratory tract. It mainly participates in the diverse physiologic

aspects of the airway protection, respiration and phonation. Negus21

prioritized three

functions of larynx. They were

1. Protection of the lower airway

2. Respiration

3. Phonation

Larynx lies at the level of third to sixth cervical vertebrae and is composed of a

framework of cartilages interconnected by muscles and ligaments. It is about 5 centimeters

long. It opens into the laryngopharynx superiorly and is continuous with the trachea

inferiorly. The unpaired cartilages are Thyroid, Cricoid, and Epiglottis, while Arytenoid,

Corniculate and cuneiform are paired cartilages.

Fig 1. The external view of the larynx

7

Fig 2. Sagittal section of the larynx

Fig 3. Cartilages of Larynx

Thyroid cartilages:

It is the largest cartilage of the larynx. It is often described as “shield shaped” and

consists of two laminae right and left. The laminae are placed obliquely relative to the

midline. Their posterior borders are far apart, but the anterior borders approach each other at

an angle of 900 in males and 120

0 in females. The lower parts of the anterior border of the

two laminae fuse and form a median projection called the laryngeal prominence. The upper

8

part of the anterior borders does not meet. They are separated by the thyroid notch. The

posterior borders are free. They are prolonged upwards and downwards as superior and

inferior cornu. The superior cornu is connected with the greater cornu of hyoid bone. The

inferior cornu articulates with the cricoid cartilage to form the cricothyroid joint.

Cricoid cartilage:

Cricoid cartilage is shaped like a signet shaped complete ring. It encircles the airway

below the thyroid cartilage and serves as a major support for the functioning of larynx. The

ring has narrow anterior part called the arch and the broad posterior part called lamina. The

lamina projects upwards behind the thyroid cartilage and articulates superiorly with the

Arytenoid cartilages. The inferior cornu of thyroid cartilage articulates with the side of

cricoid cartilage at the junction of arch and lamina.22

Epiglottis cartilage:

It is a leaf shaped elastic fibro – cartilage placed in the anterior wall of the upper part

of the larynx. The upper end is broad and free and projects upward behind the hyoid bone and

the tongue. The lower end is attached to the upper part of the angle between the two laminae

of the thyroid cartilage. It has a mucous membrane covering that reflects as a glosso-

epiglottic fold onto the pharyngeal surface of the tongue. On either side of this fold are

depressions called valleculae. The epiglottis projects into pharynx and overhangs the

laryngeal inlet.

Arytenoid cartilages:

These are two small paired, pyramid shaped cartilages. The apex articulates with the

corniculate cartilage and the base articulates with the upper border of cricoid lamina.22

Corniculate cartilages:

These are two small, paired fibro-elastic cartilages which articulate with apex of the

arytenoid cartilages and lie in the posterior part of the aryepiglottic folds.

9

Cuneiform cartilages:

These are small cartilages placed in the aryepiglottic folds just ventral to the

corniculate cartilages.

Muscles of the larynx: These are divided into,

Extrinsic muscles.

Intrinsic muscles.

There are a number of extrinsic muscles, including sternothyroid and thyrohyoid

muscles. From their position between the larynx and surrounding structures, these are

responsible for moving the larynx. The omohyoid elevates the hyoid, thereby raising the

larynx.

The intrinsic muscles include the cricoartenoid, interartenoid, thyroartenoid and the

cricothyroid muscles. Their role is to move the cartilages within the larynx. The results of

these movements are principally to adduct, abduct and adjust the tension in the vocal folds.

Nerve supply:

The nerve supply to the larynx is through the right and left superior laryngeal nerve and

recurrent laryngeal nerves, all of which are branches of vagus nerve.23

ENDOTRACHEAL TUBES24

The endotracheal tubes are the tubes through which the anaesthetic gases or vapours

along with breathing gases are conveyed to and from the trachea.

Anatomy of endotracheal tube

An endotracheal tube has two ends, the proximal and distal. The distal end is beveled

which is also called as patient end and the proximal end is called the machine end. Some

endotracheal tubes have a side hole just above and opposite the bevel called Murphy eye. It

10

mainly helps in ventilation if the bevel is occluded by secretions, blood or impenging on the

tracheal wall.

A radio opaque marker at the end of the endotracheal tube at the tip or along the

length of the tube helps in detection of the position of the tube after insertion in to the

trachea. A number of substances can be used in the manufacture of endotracheal tubes

including the neutral rubber, synthetic rubber, silicon rubber, nylon, Teflon, plastic,

polyethylene and polyvinyl chloride (PVC). The endotracheal tubes made up of synthetic

rubber and PVC is widely used nowadays. The endotracheal tubes should meet the standards

of American society for testing and materials (ASTM) and must pass a United States of

Pharmacopeia implantation.

Types of endotracheal tube

I. Depending on the route of intubation.

Oral tubes

Nasal tubes

II. Depending on presence or absence of cuff.

Uncuffed or plain tubes

Cuffed tubes

The cuff in a cuffed endotracheal tube consists of the cuff along with an inflation

system where the lumen in the wall of the tube can be inflated. The cuff connects externally

to an external inflation tube, a pilot balloon and an inflation valve. The cuff system in an

endotracheal tube provided a seal between the tube and the tracheal wall to prevent the

passage of pharyngeal content into the trachea and ensures that no gas leaks past the cuff

during positive pressure ventilation. The cuff also serves to center the tube in the trachea so

that its tip is less likely to traumatize the mucosa.

11

Fig 4. ETT made of different materials

Fig 5. ETT with cuff made from polyvinyl chloride

12

ENDOTRACHEAL INTUBATION25

Indications

Surgery of head and neck

Protection of the respiratory tract.

During anaesthesia using IPPV and muscle relaxation.

To facilitate suction of the respiratory tract.

Thoracic surgery

Cardiopulmonary arrest.

Preparations:

Availability and function of the following equipments should be checked.

Laryngoscope

Tracheal tubes

Stilette

Magill forceps

Securing tape

Catheter mount

Lubricant jelly

Throat packs

Anaesthetic breathing system and face masks

Anaesthesia for endotracheal intubation:

Adequate depth of anaesthesia is necessary to depress the laryngeal reflexes and

provide adequate degree of muscle relaxation. This can be achieved with either of the

following,

13

Local anaesthesia

o Topical spray

o Trans tracheal spray

o Superior laryngeal nerve block

Inhalational anaesthesia

Required depth can be achieved with halothane up to 4% or sevoflurane up to 8%.

This may be followed by use of nondepolarizing muscle relaxants.

Intravenous anaesthesia

Patient is induced with one of the induction agents like, thiopentone or ketamine or

Propofol. This is followed by administering depolarizing or nondepolarising muscle relaxant.

Process of intubation:

Head positioning:

The correct position for the head is “sniffing position” with the neck slightly flexed

and head extended. One places a pillow under the head and neck but not under the shoulders.

This allows a straight line of vision from the mouth to the vocal cords.

Laryngoscopy:

The laryngoscopy is held in the left hand and introduced into the right hand side of the

mouth. The tongue is swept to the left and the tip of the blade is advanced until a fold of

cartilage is visualized at 12 O` clock. This is the epiglottis, and this sits over the glottis.

The tip of the blade is advanced to the base of the epiglottis, known as the vallecula,

and the entire laryngoscope is lifted upwards and outwards. This flips the epiglottis upwards

and exposes the glottis below. An opening is seen with two white vocal cords forming a

triangle on each side.

14

Fig 6. Insertion of Endotracheal tube

Endotracheal Intubation

Intubation:

The tip of the endotracheal tube is advanced through the vocal cords to the sufficient

length. The correct position of the tube is confirmed by auscultation. The tube is secured at

this level and the cuff is inflated.26

Complications:

The complications are usually due to airway trauma, tube malpositioning,

physiological responses to airway instrumentation, or tube malfunction. These complications

can occur during laryngoscopy and intubation, while the tube is in place, or following

extubation.

During laryngoscopy and intubation:

Malpositioning

o Esophageal intubation

o Endobronchial intubation

Airway trauma

o Tooth damage

15

o Lip, tongue or mucosal injury

o Sore throat

Physiologic responses

o Hypertension

o Tachycardia

o Laryngospasm

Tube malfunction

o Cuff perforation

While the tube is in place

Malpositioning

o Unintentional extubation

o Endobronchial intubation

Airway trauma

o Mucosal inflammation and ulceration

Tube malfunction

o Ignition

o Obstruction

Following extubation

Airway trauma

o Edema and stenosis (glottis, subglottic or tracheal)

o Hoarseness of voice (vocal cord injury)

o Cough

o Difficulty in swallowing

Physiologic reflexes

o Laryngospasm

16

POST OPERATIVE SORE THROAT, COUGH AND HOARSENESS OF VOICE.

The post-operative symptoms of sore throat, cough and hoarseness after extubation is

often annoying for the patients. The exact cause of these symptoms is not clearly understood.

The selection of the size of the tube is often standardized and rarely customized. The

literature available has shown that the patients are more susceptible to sore throat after

intubation and the endotracheal tube size may be the cause of these symptoms.27

The

incidence of post-operative sore throat and hoarseness varies between 44% and 64% of those

patients surveyed.28, 29

A number of risk factors can lead to the development of post-operative

sore throat after an endotracheal intubation as follows,

Age (yrs):

o 30 – 39 Chen30

o 31 – 40 Hisham31

o ≤ 70 Honma32

Blood on the ETT Biro33

High cuff pressure Combes34

, Ratnaraj35

Duration of surgery (minutes):

o > 90 Kloub36

o > 120 Chen30

ETT size Hisham37

, Stout38

Female Sex Biro33

, Chen30

, Cheristensen39

Smoking habits Biro33

Type of surgery

o ENT Surgery Chen30

, Christensen39

o Gynecology Higgins41

Use of lidocaine spray Chen30

, Christensen39

17

Use of naso gastric tube Honma41

Use of oral airway Kyokong42

The risk factors of post-operative hoarseness in intubated patients include

Risk factor Reference

o Duration Yamanaka43

o ETT Size Stout38

, Al – Qahtani44

o Female sex Abdi45

o No use of muscle relaxant Mencke46

, Mencke47

Assessment

A variety of scales have been used to measure the post-operative sore throat. But it is

poorly defined and described by the patients simply as sore throat.48

The preferred scales to

measure the post-operative sore throat are a numeric rating scale (NRS), a visual analog scale

(VAS), dichotomous answers or a four grade scale (with numbers 0 – 3 corresponding to the

number, mild, moderate and severe pain), presented here in a random order. There is

considerable variation in the published studies on the incidence of post-operative sore throat

which can be attributed to the size of endotracheal tube used, the time–point for its

measurement as well as the scales used to measure it. Hence, there is no consensus for the

measurement of post operative sore throat. When measuring post-operative hoarseness, a

binary scale is often used rather than more invasive but more precise methods such as

stroboscope43

or voice recordings.49

There is a four grade scale which has been used in a

study by Mencke et al.50

There is no clearly defined time to measure post-operative sore

throat, but it is important to measure it in the recovery unit.51

It is also important to ask the

direct questions in order to elicit clear responses from patients about post-operative sore

throat.52

18

Prevention

General Principles After tracheal Intubation After LMA insertion

Experience of Anaesthetist

Adequate anaesthesia/

Relaxation of patient

Careful technique

Soft suction catheters

Smaller tracheal tube

Minimal cuff– tracheal

contact area

Monitoring and adjustment

of intracuff pressure

Avoidanceof local

anesthetics/ steroid lubricants

Correct size of LMA

Inflation of cuff before

insertion/ use of insertion aid

Use of KY jelly/ saline

lubricant

Minimisation of intracuff

pressure

Treatment

In most of the cases the post-operative complaints resolve spontaneously without

specific treatment. In moderate to severe cases it may be beneficial to treat pain and

dysphagia with a gargle containing a drug such as benzylamine hydrochloride, which is

approved for the symptomatic treatment of acute throat pain. It is a non-steroidal topical anti-

inflammatory agent that also has local anaesthetic activity. It has an alkaline pH, which

means that it becomes concentrated in inflamed tissue and has minimal systematic

absorption.54



of success. The pharmacological measures including Aspirin gargles, gargling with

Azulenesulphonate and Beclomethasone inhalation have been tried as per the literature

available.12, 13

The local anaesthetic agents such as lidocaine jelly or spray are known to be


These agents are


19

in preventing sore throat since they lack anti-inflammatory effects.6 The studies have also


mucosa due to its lubricating properties which suppress the bucking on the tracheal tube.15

The literature had shown that the betamethasone gel applied over the endotracheal

tube reduces the incidence of post-operative sore throat, cough and hoarseness of voice due to

its anti-inflammatory effect.16

In a study by Ayoub et al (1998), the duration of anaesthesia was 118 ± 56 min in the

placebo group and 110 ± 50 min in the steroid group. The pre-treatment with the steroid gel

markedly reduced the incidence and severity of sore throat, hoarseness of the voice and

cough. The scores for sore throat and hoarseness were significantly lower in the steroid group

at 1 hour and 24 hours. Cough tended to be less severe in the treated group, but in the

intergroup difference was not significantly different. The number of patients with neither sore

throat nor hoarseness after steroid treatment were 18 and 28 at 1 and 24 hours, respectively.

In contrast, only 4 and 13 patients reported neither sore throat nor hoarseness at 1 hour and 24

hour after lubrication with the placebo gel. The benefit of steroid application was also evident

when the incidence of patients with a score of 3 for which sore throat, hoarseness or cough

was compared at 1 hour in the placebo group versus 8 in the Betamethasone gel group and at

24 hour.4

In a study in Egypt, Kiran et al (2012) compared the effect of 0.05% betamethasone

gel with 2% lidocaine jelly. They reported that the post-operative sore throat is a minor

complication after general anaesthesia. Many agents were tried to reduce the incidence of

post-operative sore throat with variable efficacy. They conducted a study to compare the

incidence of post-operative sore throat with 0.05% betamethasone gel and 2% lidocaine jelly

as a lubricant for PLMA insertion in the patients undergoing general anaesthesia. Sixty

20

subjects were divided into two groups. Patients in group I had 2.5 ml of 0.05% of

betamethasone gel while group II had 2.5 ml of 2% lidocaine jelly applied on the cuff of

PLMA. After standard induction and insertion of PLMA cuff inflated to 60 cm of H2O and

was maintained at the same throughout the surgery. In post-operative recovery unit, patients

were enquired about sore throat at immediate and 24 hour post-operative period. The post-

operative sore throat was not observed in any of the patients of group I. In group II, 33% of

the patients had 1st degree and 10% had 2

nd degree of sore throat in immediate post-operative

period. After 24 hours 16% of the patients had the 1st degree sore throat and 3% had 2

nd

degree of sore throat in group II patients. They concluded that lubricating cuff of PLMA with

0.05% of betamethasone gel is effective in reducing the incidence of post-operative sore

throat.55

In another study by MNS Kumar (2014), Ketamine gargle, aspirin gargle and 10%

lidocaine spray was compared to prevent the incidence and severity of post-operative sore

throat, cough and hoarseness. 150 patients were randomly allocated into three groups of 50

patients each. In group K (40 mg Ketamine diluted in 29 ml of normal saline), group A (350

mg of soluble Aspirin diluted in 30 ml of distilled water) and in group L (3 puff of 10%

lidocaine was sprayed before intubation). The incidence of sore throat at 2nd

hour was 20%

(K), 20% (A) and 22% (L); cough was 20% (K), 12% (A) and 20% (L). All the patients were

free of hoarseness in first 2 hours. At 4th

hour the incidence of sore throat was 24% (K), 24%

(A) and 26% (L); cough was 16% (K), 18% (A) and 20% (L) and in the group K and A only

4% of the patients had hoarseness of grade 2 severity was decreased to 8% (K), 10% (A) and

10% (L) for sore throat: 4% (K), 6% (A) and 4% (L) for cough and all the patients were free

of hoarseness at 24th

hour. They concluded that three drugs were equally effective in reducing

the incidence and severity of post-operative sore throat, cough and hoarseness without

causing drug related side effects.56

21

In a study by Shaaban et al (2012), seventy five patients with ASA physical status I

and II, undergoing elective surgery under general anaesthesia using endotracheal intubation

were enrolled in a prospective, randomized, single blind study. The patients were randomly

divided into 3 groups of 25 patients each. Group (K) included 25 patients who were asked to

gargle with ketamine 40 mg in 30 ml saline for 60 seconds as repeated smaller attempts, 5

minutes before induction of anaesthesia. Group (B) included 25 patients whose endotracheal

tube were lubricated with 0.05% betamethasone gel. Group (C) included 25 patients who

served as control group who received neither ketamine gargle nor betamethasone gel. The

incidence and the severity of post-operative sore throat, cough and hoarseness of voice were

graded at 0, 2, 4, and 24 hours after operation by a blinded investigator. The incidence and

severity of sore throat were significantly lower in group (K) and group (B) than group (C) at

all time intervals. While there was no significant difference between the group (K) and group

(B). The incidence and severity of cough and hoarseness of voice were significantly lower in

the group (B) than group (C) and group (K) at all time intervals. They concluded that the

gargling with ketamine before induction of anaesthesia is comparable with application of

0.05% betamethasone gel over the endotracheal tubes in decreasing post-operative sore

throat. In addition, Betamethasone gel application decreased the incidence and severity of the

post-operative cough and hoarseness of voice.57

In another study by Jarahzadeh et al (2014), the study investigated the local effect of

Dexamethasone on sore throat after surgery using LMA. This study is a double blind

randomized clinical trial conducted on 100 patients who underwent general anaesthesia and

were the candidates of placement of laryngeal mask airway. The patients were randomly

assigned to two groups of 50. In the experimental group, Dexamethasone was applied to the

cuff of the LMA and in the control group; distilled water was applied to the cuff. The rate of

incidence and intensity of sore throat, prevalence of coughing and hoarseness were assessed

22

at 1, 2, and 24 hours after surgery. The incidence of sore throat during 24 hours after surgery

was 8% in Dexamethasone group and 22% in distilled water group. The intensity of pain at

the intended times after surgery significantly decreased in both the groups. The local

application of Dexamethasone on the LMA cuff was effective on reducing the prevalence and

acuity of sore throat after surgery. Regarding lack of any complications due to the use of

Dexamethasone, it can be used to prevent the post-operative sore throat.58

In a prospective, randomized, double blind controlled study by Sumathi et al (2008),

the incidence of post-operative sore throat, cough and hoarseness of voice after general

tracheal anaesthesia when applying betamethasone gel (Betamethasone gel group) or

lidocaine jelly (Lidocaine Jelly group) on the tracheal tube. One hundred and fifty ASA class

I and II patients undergoing elective surgeries under general oro tracheal anaesthesia were

randomized into three groups, betamethasone gel, lidocaine jelly and control groups. In the

post anaesthesia care unit, a blinded anaesthesiologist interviewed all patients on prospective

sore throat, cough and hoarseness of voice at 1, 6, 12 and 24 hours after operation. In the first

24 hours after surgery, the incidence of post-operative sore throat was 40, 100 and 100%;

cough was 6, 40 and 28% and hoarseness of voice was 4.1, 32.9 and 50% for the

Betamethasone gel, Lidocaine Jelly and control groups, respectively. The incidence of post-

operative sore throat, cough and hoarseness of voice was significantly lower in the

Betamethasone gel group compared with the other two groups. They concluded that wide

spread application of betamethasone gel on the tracheal tube decreases the incidence and

severity of postoperative sore throat, cough and hoarseness of voice.59

In a study Tabari et al (2013), two hundred and twenty five American Society

Anaesthesiologist (ASA) – class I and II patients undergoing elective abdominal surgery with

tracheal intubation were randomly divided into three groups, betamethasone gel, intravenous

(IV) dexamethasone and control groups. In the post anaesthesia care unit, a blinded

23

anaesthesiologist interviewed all patients regarding the post-operative sore throat at 1, 6 and

24 hours after surgery. The incidence of sore throat was significantly lower in the

betamethasone gel group compared with the IV dexamethasone and control group, 1, 6 and

24 hours after the surgery. In the first day after surgery, 10.7% of the Betamethasone gel

group had sore throat whereas 26.7% of the IV dexamethasone group and 30.7% of the

control group had sore throat. Bucking before extubation was observed in 18.4%, 10.4% and

12.2% patients, in the IV dexamethasone, betamethasone gel and control group, respectively.

They concluded that wide spread application of betamethasone gel over tracheal tubes

effectively mitigates post-operative sore throat, compared with IV dexamethasone

application.

Bagchi et al (2012), did a prospective double-blinded randomized control trial aimed

at determining the efficacy of prophylactic intravenous dexamethasone to reduce the

incidence of post-operative sore throat at 1 hour after tracheal extubation and concluded that

prophylactic intravenous dexamethasone in a dose of 0.2 mg/kg can reduce the incidence of

post-operative sore throat at 1 hour post-extubation by around 30%, with the efficacy being

around 60%.61

Kazemi A and colleagues (2007) have done study on the effect of betamethasone gel

and KY gel in reducing sore throat, cough and hoarseness after laryngo-tracheal intubation in

100 patients. Patients were interviewed at the end of the procedure, at 1hr and 24hrs after

extubation and found that betamethasone gel, when used for lubrication of endotracheal tubes

preoperatively was shown to be effective in decreasing postoperative sorethroat, cough &

hoarseness of voice.9

Dhanpal et al (2002) did a randomized double-blind study on 75 ASA I-II surgical

patients to assess the effectiveness of the application of steroid gel as compared to lidocaine

24

jelly or nothing applied to the endotracheal tube in decreasing the incidence of sore throat,

hoarseness and cough after general endotracheal anaesthesia. The patients were questioned

about these sequelae at 1,12 and 24 hours after general anaesthesia. The incidence of sore

throat was 33.30 percent in the steroid gel group vs 73.30 percent in the other two groups

(p<0.01), whereas the incidence of cough and hoarseness was 23.30 percent in the steroid gel

group, 63.30 percent in the lidocaine gel group and 50 percent in the control group.62

In another study by Park et al (2008), about 160 patients scheduled for thoracic

surgery with a DLT were enrolled. Before induction of general anaesthesia, lower and higher

doses of dexamethasone and placebo were administered. One hour after tracheal intubation,

the incidence of post-operative sore throat and hoarseness along with the severity of sore

throat were lower in the low dose dexamethasone and higher dose dexamethasone compared

with placebo group. Twenty four hours, after tracheal intubation, the incidence of post-

operative sore throat, hoarseness and severity of the sore throat were significantly lower in

high dose dexamethasone group compared with low dose dexamethasone and placebo group.

There was no complication associated with the dexamethasone administration. They

concluded that the prophylactic use of 0.2 mg/kg of dexamethasone significantly decreases

the incidence and severity of the sore throat and hoarseness at 1 hour and 24 hour after

tracheal extubation of a DLT.63

In a study by Kori et al (2009), 60 patients scheduled for general anaesthesia with

intubation were enrolled in the study. They were divided into three groups. The VAS scores

of sore throat at the end of the anaesthesia was 9.2 ± 3.4 mm in the sprayed group, 27.8 ± 5.7

mm in the lubricated group and 11.8 ± 4.4 mm in the no intervention group. VAS scores on

the next day were 2.5 ± 1.4 mm in the sprayed group, 14.0 ± 4.3 mm in the lubricated group

and 2.2 ± 1.7 mm in the no intervention group. Both VAS scores at the end of anaesthesia

and the day after anaesthesia were significantly higher in the lubricated group than others.

25

However, there was no significant difference in hoarseness among the three groups. They

concluded that VAS scores at the end of the anaesthesia and the next day were both

significantly higher in the lubricated group than in others. There was no significant difference

in the VAS between the sprayed group and the no intervention group. These data suggest that

the lidocaine jelly lubrication to the endotracheal tube reinforces the severity of the sore

throat.64

In a study by Teoh et al, one hundred and fifty once patients with American Society

of Anaesthesiologists (ASA) physical status I or II undergoing elective surgery under general

anaesthesia with tracheal tube intubation were studied. Cuffed endotracheal tubes were either

lubricated with either Lidocaine Jelly 2% or water based lubricant. Larger number of patients

in Lidocaine Jelly group complained of throat dryness at 1 hour and sore throat at 12 h.

Incidence of sore throat and throat related complaints were comparable at other time

intervals. No differences in severity of sore throat were observed and none of the patients

required further treatment. They concluded that Lidocaine Jelly 2% gel was not effective in

reducing the post intubation sore throat in comparison with water based lubricant.65

26

PHARMACOLOGY OF BETAMETHASONE

Betamethasone dipropionate gel contains betamethasone dipropionate, a synthetic

florinated corticosteroid for topical use. Betamethasone dipropionate is included in a class of

compounds consisting primarily of synthetic corticosteroids used topically as anti –

inflammatory and antipruritic agents.

Structure

Chemically, betamethasone dipropionate is 9 – fluro - 11β, 17, 21 – trihydroxy - 16β

– methyl pregna – 1,4 – diene – 3,20 – dione 17, 21- dipropionate, with the molecular

formula of C28H37FO7, a molecular weight of 504.6 and following structural formula.

Betamethasone dipropionate is a white to creamy white, odorless crystalline powder,

insoluble in water.

Clinical pharmacology

Betamethasone dipropionate has anti – inflammatory, anti-pruritic and

vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical

steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of

phospholipase A2 inhibitory proteins, collectively called lipocrotins. It is postulated that these

proteins control the biosynthesis of potent mediators of inflammation, such as prostaglandins

27

and leukotrienes, by inhibiting the release of their common precursor, arachidonic acid.

Arachidonic acid is released from the membrane phospholipids by phospholipase A2.

Pharmacokinetics

The extent of percutaneous absorption of the topical corticosteroid is determined by

many factors including the vehicle and the integrity of the epidermal barrier. Occlusive

dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase the

penetration; however, occlusion of the hydrocortisone for 96 hours markedly enhances

penetration. Topical corticosteroids can be absorbed from normal intact skin. In addition,

inflammation and/or other disease processes in the skin and mucous membranes may increase

the percutaneous absorption. Studies performed with betamethasone dipropionate gel indicate

that it is in the superior range of potency as compared with other topical corticosteroids.

Indication and usage for betamethasone gel

Betamethasone dipropionate gel is a superior high potency corticosteroid indicated for

the relief of the inflammatory and pruritic manifestations of corticosteroid responsive

dermatoses. It is also used as preventive medication to prevent the post-operative hoarseness,

cough and sore throat.

Contraindications

Betamethasone dipropionate gel is contraindicated in those patients with a history of

hypersensitivity to any of the components of the preparation.

28

Fig 7. Betamethasone Gel

29

PHARMACOLOGY OF LIDOCAINE JELLY

Lidocaine hydrochloride jelly USP, 2% is a sterile aqueous product that contains a

local anaesthetic agent and is administered topically.

Lidocaine hydrochloride jelly USP, 2% contains lidocaine hydrochloride which is

chemically designated as acetamide, 2-(diethyl-amino)-N-(2,6-dimethylphenyl)-,

monohydrochloride and has the following structural formula:

Lidocaine hydrochloride jelly USP, 2% also contains hypromellose, and the resulting

mixture maximizes contact with mucosa and provides lubrication for instrumentation. The

unused portion should be discarded after initial use.

Composition of lidocaine hydrochloride jelly USP, 2%: Each mL contains 20 mg of

lidocaine hydrochloride. The formulation also contains the following inactive ingredients:

methylparaben, propylparaben, hypromellose, sodium hydroxide, and purified water. May

contain hydrochloric acid or additional sodium hydroxide, if necessary to adjust pH to 6.0 to

7.0.

Clinical Pharmacology

Mechanism of Action

Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for

the initiation and conduction of impulses, thereby effecting local anaesthetic action.

30

Onset of Action

The onset of action is 3 to 5 minutes. It is ineffective when applied to intact skin.

Hemodynamics

Excessive blood levels may cause changes in cardiac output, total peripheral

resistance, and mean arterial pressure. These changes may be attributable to a direct

depressant effect of the local anaesthetic agent on various components of the cardiovascular

system.

Pharmacokinetics and Metabolism

Lidocaine may be absorbed following topical administration to mucous membranes,

its rate and extent of absorption depending upon concentration and total dose administered

the specific site of application, and duration of exposure. In general, the rate of absorption of

local anaesthetic agents following topical application occurs most rapidly after intratracheal

administration. Lidocaine is also well-absorbed from the gastrointestinal tract, but little intact

drug may appear in the circulation because of biotransformation in the liver.

Lidocaine is metabolized rapidly by the liver, and metabolites and unchanged drug are

excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring

hydroxylation, cleavage of the amide linkage, and conjugation. N-dealkylation, a major

pathway of biotransformation, yields the metabolites monoethylglycinexylidide and

glycinexylidide. The pharmacological/toxicological actions of these metabolites are similar

to, but less potent than, those of lidocaine. Approximately 90% of lidocaine administered is

excreted in the form of various metabolites, and less than 10% is excreted unchanged. The

primary metabolite in urine is a conjugate of 4-hydroxy-2,6-dimethylaniline.

31

The plasma binding of lidocaine is dependent on drug concentration, and the fraction

bound decreases with increasing concentration. At concentrations of 1 to 4 mcg of free base

per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the

plasma concentration of the alpha-1-acid glycoprotein.

Lidocaine crosses the blood-brain and placental barriers, presumably by passive

diffusion.

Studies of lidocaine metabolism following intravenous bolus injections have shown

that the elimination half-life of this agent is typically 1.5 to 2.0 hours. Because of the rapid

rate at which lidocaine is metabolized, any condition that affects liver function may alter

lidocaine kinetics. The half-life may be prolonged twofold or more in patients with liver

dysfunction. Renal dysfunction does not affect lidocaine kinetics but may increase the

accumulation of metabolites.

Factors such as acidosis and the use of CNS stimulants and depressants affect the

CNS levels of lidocaine required to produce overt systemic effects. Objective adverse

manifestations become increasingly apparent with increasing venous plasma levels above 6.0

mcg free base per mL. In the rhesus monkey arterial blood levels of 18 to 21 mcg/mL have

been shown to be threshold for convulsive activity.

Indications and Usage for Lidocaine Jelly

Lidocaine hydrochloride jelly, 2% is indicated for prevention and control of pain in

procedures involving the male and female urethra, for topical treatment of painful urethritis,

and as an anaesthetic lubricant for endotracheal intubation (oral and nasal).

32

Contraindications

Lidocaine is contraindicated in patients with a known history of hypersensitivity to

local anaesthetics of the amide type or to other components of lidocaine hydrochloride jelly,

2%.

Fig 8: Lidocaine Jelly

33

PHARMACOLOGY OF LUBRICATING JELLY66, 67

Jellies are clear, transparent semisolids containing considerable amount of water and

suitable as vehicles. The lubricating jelly contains the synthetic and vegetable gums. They are

water soluble, greaseless, non-irritating and ideal for general lubricating needs. Jellies are

often used in Per vaginal examination, as a sonic aid, helps in insertion of instruments, per

rectal examination, catheterization of urinary bladder, electrophysiological studies,

endoscopies and also in anaesthesia as prevention of sore throat, hoarseness and cough after

intubation. The lubrication facilitates the insertion of the instruments in the human organs and

minimizes the discomfort to the patient. In endoscopy, it prevents the friction between the

tube (sheath) of the endoscope and body tissue. The lack of lubrication many results in

friction between the body tissue and the scope and will not facilitate the proper entry of the

tube and cause discomfort to the patients.

Properties of an ideal lubricating jelly

The main purpose of using lubricating jelly is for lubrication, it should

nowhere affect the other physiological functions of the body.

Non medicated jelly prevents the risk of side effects.

Good viscosity facilitates the adherence of the jelly to the tube.

Sterile jelly reduces the risk of contamination.

Non-irritant property prevents the discomfort and anxiety to the patient.

Water solubility provides the soothing effect on the body tissue and facilitates

the easy washing of the instrument after use.

Odorless and Tasteless helps in improvement of the patient compliance.

Greacelessness facilitates the easy application on the instrument and prevents

the damage to the instrument or the optical system.

34

Problems associated with the conventionally used jellies

The medicated preparation increases the risk of side effects.

The jellies have risk of contamination and thus increasing the risk

infection.

Advantages of the lubricating jelly

Good lubricating properties.

Adheres to the surgical instrument.

Facilitates the advancement of the tube.

Protects the delicate tissues of the body.

Can be washed of easily and has soothing effect on the body tissue.

Easily accepted by the patient.

Can be applied easily to the scope.

Protect the component of the scope.

Fig 9: Lubic Jelly

35

MATERIALS AND METHODS

A randomized controlled study was conducted among patients who were posted

for elective surgeries under general anaesthesia with orotracheal intubation at MVJ medical

college and research hospital, Hoskote, Bangalore. 153 patients who satisfied the inclusion

and exclusion criteria were included in the study. Clearance from the institutional ethical

committee was obtained before the study was conducted. An informed, bilingual and written

consent was taken before the study was started. The inclusion and exclusion criteria for the

patients were as follows,

Inclusion criteria: Adults with

o Age group: 18- 60 years.

o Physical status ASA class I-II

o Undergoing elective surgeries

o Duration of surgery <240 minutes.

Exclusion criteria: Adults with

o Surgeries of oral cavity and pharynx or with anticipated difficult

airway.

o More than 2 attempts at intubation

o Use of nasogastric tube or throat packs

o Patients with upper respiratory tract infection.

o Patients on steroid therapy.

Method of collection of data:

After pre anaesthetic evaluation, 153 patients of either sex, aged between 18 and 60

yrs, belonging to ASA physical status class I or II, undergoing elective surgery (likely to last

Figure 9

36

up to 240 min) under general anaesthesia with orotracheal intubation with the above

mentioned inclusion criteria were included in the study.

Patients were randomized into the following three equal groups by computer-

generated random number table and sealed envelope method:

Betamethasone gel group: betamethasone gel 0.05% (Betagel, Micro Labs Limited,

Bangalore, India)

Lidocaine Jelly group: Lidocaine Jelly 2% (Xylocaine2% jelly, Astra Zeneca Pharma

India Limited, Bangalore, India)

Lubricating jelly group: Lubic jelly sterile (synthetic and vegetable gums, Neon

Laboratories Limited, Mumbai).

All patients were pre-medicated with tab. Alprazolam 0.5 mg and tab. Ranitidine

150 mg orally10hrs before surgery.

The PVC tracheal tube (Portex Profile tracheal tube) was lubricated from the distal

end of the cuff to a distance of 15cm from the tip using 2.5ml of betamethasone gel, lidocaine

jelly or lubricating water based jelly, spread uniformly with sterile precautions. Single use

PVC tracheal tubes (Portex Profile tracheal tube), having low-pressure–high-volume cuffs, of

appropriate size( Females 7.0-7.5 mm ID & Males 8.0-8.5 mm ID) were used. After

connecting to standard monitors, with I.V. access and preoxygenation, anaesthesia was

induced with I.V.fentanyl 2µg/kg and thiopental sodium 5mg/kg. IV, succinylcholine 1.5

mg/kg IV was used for tracheal intubation.

All intubations were performed by an anaesthesiology resident, who was blinded

to group allocation. Immediately after intubation, the tracheal tube cuff was inflated with just

enough room air to prevent an audible leak. Anaesthesia was maintained with nitrous oxide

37

66%, halothane 0.5–1% in oxygen, and I.V. vecuronium bromide was repeated intermittently

to maintain one to two twitches on train-of-four stimulation of ulnar nerve.

At the end of the surgery, 100% oxygen was administered and residual

neuromuscular block was antagonized with inj. Glycopyrolate 0.01mg/kg and inj.

Neostigmine 0.05 mg/kg. Oral suctioning was done just before extubation only. The patient

was extubated after deflating the cuff, when the TOF ratio was at least 70% and patient fully

awake. Assessment of patients for post-operative sore throat, cough, and hoarseness of voice

at 1, 6, 12, 24 hrs after surgery was carried out by the anaesthetist in charge of the post

anaesthesia care unit, blinded to the group allocation, using the questionnaire.

Score

Sore throat

0. No sore throat at any time since the extubation

1. Minimal sore throat

2. Moderate sore throat

3. Severe sore throat

Cough

0. No cough at any time since the extubation

1. Minimal cough or scratchy throat

2. Moderate cough

3. Severe cough

38

Hoarseness

0. No evidence of hoarseness at any time since the extubation

1. No evidence of hoarseness at the time of interview

2. Hoarseness at the time of interview noted by patient only

3. Hoarseness that is easily noted at the time of interview

Statistical analysis:

The data thus collected was entered in an excel sheet and was transported to the

Statistical Package for Social Services (SPSS vs 20). The categorical data was analysed using

the frequencies and percentages. The quantitative data was presented by using measures of

the central tendency. The Chi square test was used as the significance test for the categorical

variables and Analysis of Variance was used as the test of significance for the quantitative

variables.

39

RESULTS

Table 1. Distribution of the study group according to age group

Age group Betamethasone

gel group

n (%)

Lidocaine

Jelly group

n (%)

Water based

Lubricating jelly

group

n (%)

Less than 20 years 2 (3.9) 4 (8.0) 4 (7.7)

21 – 30 years 18 (35.3) 18 (36.0) 20 (38.5)

31 – 40 years 14 (27.5) 13 (26.0) 14 (26.9)

41 – 50 years 9 (17.6) 9 (18.0) 10 (19.2)

51 – 60 years 8 (15.7) 6 (12.0) 4 (7.7)

Total 51 (100) 50 (100) 52 (100)

χ2 Value= 2.343 df=8 p value=0.969, NS

Chart 1. Distribution of the study group according to age group

Table and chart no 1 shows the distribution of the study group according to the age

group. About 35.3% of the patients in the Betamethasone gel group, 36.0% in Lidocaine Jelly

group and 38.5% of the Water based lubricating jelly group belonged to 21 – 30 years of age

group. There was no significant difference between the ages of three groups. Hence, all the

three groups were comparable with respect to age group.

3.9

35.3

27.5

17.6 15.7

8

36

26

18

12

7.7

38.5

26.9

19.2

7.7

0

5

10

15

20

25

30

35

40

45

Less than20 years

21 – 30 years

31 – 40 years

41 – 50 years

51 – 60 years

Betamethasone group

Lignocaine group

Lubricating jelly group

40

Table 2. Distribution of the study group according to sex

Sex Betamethasone

gel group

n (%)

Lidocaine

Jelly group

n (%)

Water based

lubricating jelly

group

n (%)

Male 19 (37.3) 15 (30.0) 18 (34.6)

Female 32 (62.7) 35 (70.0) 34 (65.4)

Total 51 (100) 50 (100) 52 (100)


Chart 2. Distribution of the study group according to sex

62.7% of the patients of Betamethasone gel group, 70.0% of the Lidocaine Jelly group

and 65.4% of the patients belonging to Lubricating jelly group were females. There was no

significant difference between the sex and three groups.

0

10

20

30

40

50

60

70

Betamethasonegroup

Lignocaine group Lubricating jellygroup

37.3

30 34.6

62.7

70 65.4

Male

Female

41

Table 3. Distribution of the study group according to ASA grade

ASA Grade Betamethasone gel

group

n (%)

Lidocaine Jelly

group

n (%)

Water based

lubricating jelly

group

n (%)

I 29 (56.9) 32 (64.0) 37 (71.2)

II 22 (43.1) 18 (36.0) 15 (28.8)

Total 51 (100) 50 (100) 52 (100)


Chart 3. Distribution of the study group according to ASA grade

56.9% of the patients in Betamethosone group, 64.0% in the Lidocaine Jelly group

and 71.2% in the Water based lubricating jelly group belonged to grade I of American

Society of Anesthesiologist grade. There was no significant difference between the ASA

grade in different groups.

0

10

20

30

40

50

60

70

80

Betamethasonegroup

Lignocaine group Lubricating jellygroup

56.9

64

71.2

43.1

36

28.8 I

II

42

Table 4. Distribution of the study group according to Sore throat at 1 hour

Sore throat at 1 hour Betamethasone

gel group

n (%)

Lidocaine

Jelly group

n (%)

Water based

lubricating

jelly group

n (%)

No sore throat at any time

since the time of extubation

12 (23.5) 13 (26.0) 35 (67.3)

Minimal sore throat 22 (43.1) 4 (8.0) 16 (30.8)

Moderate sore throat 16 (31.4) 26 (52.0) 1 (1.9)

Severe sore throat 1 (2.0) 7 (14.0) 0

Total 51 (100) 50 (100) 52 (100)

χ2 Value= 61.715 df=6 p value=0.000, Sig

Chart 4. Distribution of the study group according to Sore throat at 1 hour

Table and chart no 4 shows the distribution of the sore throat at 1 hour in

Betamethasone gel group, Lidocaine Jelly group and Water based lubricating jelly group. In

Betamethasone gel group, about 43.1% of the patients had minimal sore throat, in Lidocaine

Jelly group, about 52.0% of the patients had moderate sore throat and in Water based

lubricating jelly group, 67.3% had no sore throat at any time since the extubation. There was

a significant difference between the occurrence of sore throat at 1 hour and different three

treatment groups.

23.5

43.1

31.4

2

26

8

52

14

67.3

30.8

1.9 0 0

10

20

30

40

50

60

70

80

No sore throatat any time

since the timeof extubation

Minimal sorethroat

Moderate sorethroat

Severe sorethroat

Betamethasone group

Lignocaine group


43

Table 5. Distribution of the study group according to Sore throat at 6 hours

Sore throat at 6 hours Betamethasone

group

n (%)

Lidocaine Jelly

group

n (%)

Water based

lubricating jelly

group

n (%)



14 (27.5) 11 (22.0) 41 (78.8)

Minimal sore throat 24 (47.1) 10 (20.0) 11 (21.2)

Moderate sore throat 13 (25.5) 23 (46.0) 0

Severe sore throat 0 6 (12.0) 0

Total 51 (100) 50 (100) 52 (100)


Chart 5. Distribution of the study group according to Sore throat at 6 hours

At the end of 6 hours, 47.1% of the patients in the Betamethasone gel group had the

minimal sore throat, 46.0% in the Lidocaine Jelly group had moderate sore throat and 78.8%

in the Water based lubricating jelly group had no sore throat at any time since the time of

extubation. There was a significant difference between the three treatment groups in the

occurrence of sore throat.

0

10

20

30

40

50

60

70

80

No sorethroat at any

time sincethe time ofextubation

Minimalsore throat

Moderatesore throat

Severe sorethroat

27.5

47.1

25.5

0

22 20

46

12

78.8

21.2

0 0

Betamethasone group

Lignocaine group


44


Sore throat at 12 hours Betamethasone

gel group

n (%)

Lidocaine Jelly

group

n (%)

Water based

lubricating jelly

group

n (%)



39 (76.5) 32 (64.0) 52 (100)

Minimal sore throat 10 (19.6) 9 (18.0) 0

Moderate sore throat 2 (3.9) 6 (12.0) 0


Total 51 (100) 50 (100) 52 (100)



At the end of 12 hours, 76.5% of the patients in Betamethasone gel group, 64.0% in

the Lidocaine Jelly group and no patients in Water based lubricating jelly group had sore

throat. In Betamethasone gel group 19.6% had minimal sore throat and 3.9% had moderate

sore throat. In Lidocaine Jelly group, 18% had minimal sore throat, 12.0% had moderate sore

throat and 6% had severe throat at 12 hours. There was a significant difference between the

occurrence of sore throat at 12 hours in three different treatment groups.

0

20

40

60

80

100

No sorethroat at any

time sincethe time ofextubation

Minimal sorethroat

Moderatesore throat

Severe sorethroat

76.5

19.6

3.9 0

64

18 12

6

100

0 0 0

Betamethasone group

Lignocaine group


45


Sore throat at 24 hours Betamethasone gel

group

n (%)

Lidocaine Jelly

group

n (%)

Water based

lubricating jelly

group

n (%)



47 (92.2) 40 (80.0) 52 (100)

Minimal sore throat 4 (7.8) 5 (10.0) 0

Moderate sore throat 0 2 (4.0) 0


Total 51 (100) 50 (100) 52 (100)



At the end of 24 hours, 92.2% in Betamethasone gel group, 80% in the Lidocaine

Jelly group and all the patients in Water based lubricating jelly group had no sore throat. In

Betamethasone gel group, about 7.8% had minimal sore throat. In Lidocaine Jelly group,

10% had minimal sore throat, 4% had moderate sore throat and 6% had severe sore throat.

This difference in occurrence of sore throat at 24 hours was significant difference between

the three treatment groups.

92.2

7.8 0 0

80

10 4 6

100

0 0 0 0

20

40

60

80

100

120

No sore throatat any time

since the time ofextubation

Minimal sorethroat

Moderate sorethroat

Severe sorethroat

Betamethasone group

Lignocaine group


46

Table 8. Distribution of the study group according to cough at 1 hour

Cough at 1 hour Betamethasone

gel group

n (%)

Lidocaine Jelly

group

n (%)

Water based

lubricating jelly

group

n (%)

No cough at any time since

the time of extubation

23 (45.1) 18 (36.0) 49 (94.2)

Minimal cough or scratchy

throat

16 (31.4) 9 (18.0) 3 (5.8)

Moderate cough 12 (23.5) 19 (38.0) 0

Severe cough 0 4 (8.0) 0

Total 51 (100) 50 (100) 52 (100)


Chart 8. Distribution of the study group according to cough at 1 hour

At the end of 1 hour, in Betamethasone gel group, about 45.1% had no cough, 31.4%

had minimal cough and 23.5% had moderate cough. In Lidocaine Jelly group, 36% had no

cough, 18% had minimal cough, 38% had moderate cough and 8.0% had severe cough. In the

Water based lubricating jelly group, 94.2% of the patients had no cough and 5.8% had

minimal cough. There was a significant difference in occurrence of cough between the three

different treatment groups.

0

10

20

30

40

50

60

70

80

90

100

No cough atany time since

the time ofextubation

Minimalcough orscratchythroat

Moderatecough

Severe cough

45.1

31.4 23.5

0

36

18

38

8

94.2

5.8 0 0

Betamethasone group

Lignocaine group


47

Table 9. Distribution of the study group according to cough at 6 hours

Cough at 6 hours Betamethasone

gel group

n (%)

Lidocaine Jelly

group

n (%)

Water based

lubricating jelly

group

n (%)



29 (56.9) 18 (36.0) 51 (98.1)


throat

14 (27.5) 10 (20.0) 1 (1.9)

Moderate cough 8 (15.7) 17 (34.0) 0


Total 51 (100) 50 (100) 52 (100)


Chart 9. Distribution of the study group according to cough at 6 hours

At the end of 6 hours, 56.9% of the patients in the Betamethasone gel group had no

cough, 27.5% had minimal cough and 15.7% had moderate cough. In Lidocaine Jelly group

36% had no cough, 20% had minimal cough, 34% had moderate cough and 10% had severe

cough. In the water based lubricating jelly group, 98.1% had no cough and 1.9% had minimal

cough or scratchy cough. There was a significant difference between the treatment groups in

the occurrence of cough at 6 hours.

0102030405060708090

100

No cough atany timesince thetime of

extubation


Moderatecough

Severe cough

56.9

27.5

15.7

0

36

20

34

10

98.1

1.9 0 0

Betamethasone group

Lignocaine group


48



gel group

n (%)

Lidocaine Jelly

group

n (%)

Water based

lubricating jelly

group

n (%)



49 (96.1) 38 (76.0) 52 (100)


throat

2 (3.9) 3 (6.0) 0

Moderate cough 0 7 (14.0) 0


Total 51 (100) 50 (100) 52 (100)



There was no cough at 12 hours in 96.1% of the patients of Betamethasone group and

3.9% had minimal cough. In Lidocaine Jelly group, 76% had no cough, 6% had minimal

cough, 14% had moderate cough and 4% had severe cough. None of the patients had Water

based lubricating jelly group had cough. There was a significant difference between the three

treatment groups in the occurrence cough at 12 hours.

96.1

3.9 0 0

76

6 14

4

100

0 0 0 0

20

40

60

80

100

120

No cough atany timesince thetime of

extubation


Moderatecough

Severecough

Betamethasone group

Lignocaine group


49



gel group

n (%)

Lidocaine Jelly

group

n (%)

Water based

lubricating jelly

group

n (%)



49 (96.1) 42 (84.0) 52 (100)


throat

1 (2.0) 3 (6.0) 0

Moderate cough 1 (2.0) 4 (8.0) 0


Total 51 (100) 50 (100) 52 (100)



In the Betamethasone gel group, 96.1% of the patients had no cough at the end of 24

hours, 2% had minimal cough and 2% had moderate cough. In the Lidocaine Jelly group,

84% had no cough, 6% had minimal cough, 8% had moderate cough and 2% had severe

cough. In the Water based lubricating jelly group, none of the patients had cough at the end

of 24 hours.

0

10

20

30

40

50

60

70

80

90

100

No coughat any time

since thetime of

extubation


Moderatecough

Severecough

96.1

2 2 0

84

6 8 2

100

0 0 0

Betamethasone group

Lignocaine group


50

Table 12. Distribution of the study group according to hoarseness at 1 hour

Hoarseness at 1 hour Betamethasone

gel group

n (%)

Lidocaine Jelly

group

n (%)

Water based

lubricating jelly

group

n (%)

No evidence of hoarseness at

any time since the extubation

16 (31.4) 13 (26.0) 37 (71.2)


the time of interview

20 (39.2) 5 (10.0) 13 (25.0)

Hoarseness at the time of

interview noted by patient

only

14 (27.5) 18 (36.0) 2 (3.8)

Hoarseness that is easily

noted at the time of interview

1 (2.0) 14 (28.0) 0

Total 51 (100) 50 (100) 52 (100)


51

Chart 12. Distribution of the study group according to hoarseness at 1 hour

At the end of 1 hour in Betamethasone gel group, about 31.4% had no evidence of

hoarseness at any time since the extubation, 39.2% had no evidence of hoarseness at the time

of interview, 27.5% had the hoarseness at the time of interview noted by patient and 2.0%

had hoarseness that is easily noted at the time of interview. In the Lidocaine Jelly group,

26.0% had no hoarseness since operation, 10% had no evidence of hoarseness at the time of

interview, 36.0% had hoarseness noted by patient and 28% had hoarseness that is easily noted

at interview. 71.2% of the patients in Water based lubricating jelly group had no evidence of

hoarseness since extubation, 25.0% had no evidence of hoarseness at the time of interview

and 3.8% had hoarseness easily noted at the time of interview. There was a significant

difference between the three treatment groups and occurrence of hoarseness at 1 hour.

0

20

40

60

80

No evidence ofhoarseness atany time sincethe extubation

No evidence ofhoarseness at

the time ofinterview

Hoarseness atthe time ofinterviewnoted by

patient only

Hoarsenessthat is easilynoted at the

time ofinterview

31.4 39.2

27.5

2

26

10

36 28

71.2

25

3.8 0

Betamethasone group

Lignocaine group


52

Table 13. Distribution of the study group according to hoarseness at 6 hours

Hoarseness at 6 hours Betamethasone

gel group

n (%)

Lidocaine Jelly

group

n (%)

Water based

lubricating jelly

group

n (%)



18 (35.3) 13 (26.0) 40 (76.9)



19 (37.3) 10 (20.0) 10 (19.2)



only

13 (25.5) 17 (34.0) 2 (3.8)



1 (2.0) 10 (18.0) 0

Total 51 (100) 50 (100) 52 (100)


53

Chart 13. Distribution of the study group according to hoarseness at 6 hours

At the end of 6 hours, in Betamethasone gel group about 35.3% of the patients had no

evidence of hoarseness, 37.3% had no evidence of hoarseness at the time of interview, 25.5%

had hoarseness at the time of interview noted by patient and 2% had hoarseness easily noted

at the time of interview. In Lidocaine Jelly group, 26% had no evidence of hoarseness, 20%

had no evidence of hoarseness at the time of interview, 34% had hoarseness at the time of

interview noted by patient and 18% had hoarseness that is easily noted at the time of

interview. In Water based lubricating jelly group, about 76.9% of the patients had no

evidence of hoarseness at any time, 19.2% had no evidence of hoarseness at the time of

interview and 3.8% had hoarseness at the time of interview noted by the patient. There was a

significant difference between the different degrees of hoarseness and three treatment groups.

35.3 37.3

25.5

2

26 20

34

18

76.9

19.2

3.8 0

0

10

20

30

40

50

60

70

80

90

No evidenceof hoarseness

at any timesince the

extubation

No evidenceof hoarsenessat the time of

interview

Hoarseness atthe time ofinterviewnoted by

patient only


time ofinterview

Betamethasone group

Lignocaine group


54



gel group

n (%)

Lidocaine Jelly

group

n (%)

Water based

lubricating jelly

group

n (%)



42 (82.4) 26 (52.0) 50 (96.2)



7 (13.7) 8 (16.0) 2 (3.8)



only

2 (3.9) 8 (16.0) 0



0 8 (16.0) 0

Total 51 (100) 50 (100) 52 (100)


55


At the end of 12 hours, about 82.4% had no evidence of hoarseness at any time ,

13.7% had no evidence of hoarseness at the time of interview and 3.9% had hoarseness at the

time of interview noted by the patient in the Betamethasone gel group. In Lidocaine Jelly

group, 52% had no evidence of hoarseness at any time, 16% had no evidence of hoarseness at

the time of interview, 16% had hoarseness noted by patient, and 16% had hoarseness that is

easily noted at the time of interview. In the Water based lubricating jelly group, 96.2% had

no evidence of hoarseness at any time and 3.8% had no evidence of hoarseness at the time of

interview. There was a significant difference between the three treatment groups in

occurrence of hoarseness at 12 hours.

0

20

40

60

80

100

No evidenceof

hoarsenessat any time

since theextubation

No evidenceof

hoarsenessat the time of

interview

Hoarsenessat the time of

interviewnoted by

patient only


time ofinterview

82.4

13.7 3.9 0

52

16 16 16

96.2

3.8 0 0

Betamethasone group

Lignocaine group


56



gel group

n (%)

Lidocaine Jelly

group

n (%)

Water based

lubricating jelly

group

n (%)



46 (90.2) 47 (94.0) 49 (94.2)



2 (3.9) 1 (2.0) 3 (5.8)



only

0 1 (2.0) 0



3 (5.9) 1 (2.0) 0

Total 51 (100) 50 (100) 52 (100)


57


In the Betamethasone gel group, about 90.2% of the patients had no evidence of hoarseness,

3.9% had no evidence of hoarseness at the time of interview by patient and 5.9% had

hoarseness that is easily noted at the time of interview. In the Lidocaine Jelly group, 94% had

no evidence of hoarseness since operation, 2% had no evidence of hoarseness at the time of

interview, 2% had hoarseness at the time of interview noted by patient only and 2% had

hoarseness that is easily noted at the time of interview. In Water based lubricating jelly

group, 94.2% had no evidence of hoarseness at any time after operation and 5.8% had no

evidence of hoarseness at the time of interview. There was no significant difference in the

occurrence of hoarseness at 24 hours after operation between the three groups.

0

10

20

30

40

50

60

70

80

90

100

No evidenceof

hoarsenessat any time

since theextubation

No evidenceof

hoarsenessat the time of

interview

Hoarsenessat the time of

interviewnoted by

patient only


time ofinterview

90.2

3.9 0

5.9

94

2 2 2

94.2

5.8 0 0

Betamethasone group

Lignocaine group


58

DISCUSSION

The artificial maintenance of airway is the essence of general anaesthesia. The airway

is often established during general anaesthesia by endotracheal intubation. It has advantages

including the provision of the reliable airway, prevention of aspiration and smooth delivery of

the anaesthetic gases. But, all the patients who were intubated for long term or short term

operations, experience some degrees of airway injury. The usual complications of the airway

include airway trauma, physiological reflexes like tachycardia and hypertension, malposition,

laryngospasm, narrowing and increased airway resistance as well as negative pressure

pulmonary oedema.2


uncomfortable sequelae after tracheal intubation.4

The prevalence of these complications

were reported to be around 21% - 65% as per the literature available.4 The incidence of sore

throat during the placement (insertion) of the laryngeal mask airway is reported to be 34% -

58%.5,6

The wide variation on these figures is presumably due to different skills and

techniques of anaesthetists and to differences between individual anaesthetists and patients in

the definition of sore throat. 54

Post-operative sore throat represents a broad constellation of signs and symptoms.

The expression sore throat is obviously common to the vernacular of many different cultures,

yet it provides at best a parsimonious description of the actual phenomena. The simplest form

of sore throat in a lay description is called pharyngitis, which in itself can have a variety of

causes. However sorethroat may also include a variety of symptoms including laryngitis,

tracheitis, hoarseness, cough or dysphagia. Postoperatively, it seems most plausible that the

symptoms are the result of mucosal injury with resulting inflammation caused by the process

59

of airway instrumentation (i.e. laryngoscopy & suctioning) or the irritating effects of a

foreign object ( i.e. endotracheal tube, LMA or oral airway ). 68

Even though these complications are minor, they contribute significantly to the post-

operative morbidity and may decrease the patient satisfaction with their anaesthetic and

surgical experience.5, 6



of success. The small sized endotracheal tubes, lubricating the endotracheal tubes with water

soluble jelly, careful airway instrumentation, intubation after full relaxation, minimizing the

intracuff pressure, gentle oropharyngeal suctioning and extubation when the tracheal tube

cuff is fully deflated are some non-pharmacological measures followed to prevent these

complications.10, 11

The pharmacological measures including Aspirin gargles, gargling with

azulenesulphonate, ketamine gargle, Strepsils lozenges 68

and beclomethasone inhalation

have been tried as per the literature available.12, 13

The studies have also proven that the

application of local anaesthetic jelly limits the potential damage to the tracheal mucosa due

to its lubricating properties which suppress the bucking on the tracheal tube.15

The application of Betamethasone gel over the endotracheal tube reduces the

incidence of post-operative sore throat, cough and hoarseness of voice due to its anti-

inflammatory effect.16

The lubrication mechanism is largely a function of surface property modification, an

effective lubricant usually interacts with the surface of the interventional device and are

modified to minimize co-efficient of friction. There are two primary methods to minimize co-

efficient of friction (1) Hydrophobic (2) Hydrophilic. Hydrophilic method is activated by

60

aqueous environment, a layer of slippery hydrogel is created on the device surface reducing

the friction force.69,70,71

The studies available have shown inconsistent results to prevent sore throat, cough

and hoarseness of the voice across the world and India. Hence, this study was undertaken in

order to establish the safety, efficacy and outcome of application of Betamethasone gel,

Lidocaine jelly and water based lubricating jelly.

A randomized controlled study was undertaken in the patients who were posted for

elective surgeries under general anaesthesia with orotracheal intubation at MVJ medical

college and research hospital, Hoskote, Bengaluru. The study group had 153 patients who

satisfied the inclusion and exclusion criteria and were further divided into three groups

namely Betamethasone gel, Lidocaine jelly and water based lubricating jelly ( lubic).

Age distribution of the patients;

35.3% of the patients in the Betamethasone group, 36.0% in Lidocaine Jelly group

and 38.5% of the water based lubricating jelly group belonged to 21 – 30 years of age group.

The mean age of the subjects in Betamethasone gel group was 36.65 years, Lidocaine jelly

group was 35.52 years and Water based lubricating jelly group was 34.13. Hence, all the

three groups were comparable with respect to age. In a study by Kiran et al, the mean age of

the subjects in Betamethasone gel was 32.12 years and Lidocaine jelly was 30.84 years.55

In a

study by Jarahzadeh et al, the mean age of Dexamethasone group was 46.9 years and 45.96

years in the control group.58

In a similar study by Sumathi et al, the mean age of the patients

in the Betamethasone gel group was 32 years, Lidocaine Jelly group was 33 years and 32

years in the control group.59

In a study by Tabari et al, the mean age of the Betamethasone gel

group was 42.35 years, IV Dexamethasone group was 41.5 years and 40.52 years in control

group.60

In a study by Teoh et al, the mean age was 41.4 years in the Betamethasone gel

61

group and 44.4 years in the Water based jelly group.65

The age distribution in our study

groups correlates with the study done by Sumathi et al.

Sex

62.7% of the patients of Betamethasone gel group, 70.0% of the Lidocaine Jelly

group and 65.4% of the patients belonging to Water based lubricating jelly group were

females. The statistical non significance also shows that the three groups were comparable

with respect to sex. In a study by Kiran et al, most of the study subjects in Betamethasone gel

group were females and in Lidocaine Jelly group were males.55

In a similar study, Sumathi et

al reported that most of the patients were males in Betamethasone gel, Lidocaine Jelly and

Control groups.59

In a study by Tabari et al, majority of the study subjects were males.60

In a

study by Teoh et al, about 66% of the patients in the Betamethasone gel group and 65% of

the water based jelly group were males.65

In a study by Jarahzadeh et al 58% of experimental

group and 50% of control group were females.

Hence our study has statistical correlation

with the study of Jarahzadeh et al.

ASA grade

About 56.9% of the patients in Betamethasone gel group, 64.0% in the Lidocaine

Jelly group and 71.2% in the Water based lubricating jelly group belonged to grade I of

American Society of Anesthesiologists grade. There was no significant difference between

the ASA grade and different groups. No studies were available to compare these results.

Sore throat

At the end of 1 hour. In Betamethasone gel group, 43.1% of the patients had minimal sore

throat, 31.4% had moderate sore throat, 2% had severe sore throat and 23.5% had no sore

throat since the extubation.

62

In Lidocaine Jelly group, 8%of the patients had minimal sore throat, 52.0% of the patients

had moderate sore throat, 14% of patients had severe sore throat and 26% of the patients had

no sore throat at any time after extubation.

In Water based lubricating jelly group, 30.8% of the patients had minimal sore throat,

1.9%of patients had moderate sore throat and 67.3% had no sore throat at any time since the

extubation.

In a study by Kiran et al, about 43.3% of the study subjects in Lidocaine Jelly group had

mild sore throat and 10.0% had moderate sore throat at immediate post-operative period.

None of the patients had severe sore throat immediately after operation.55

In a study in

Jarahzadeh et al, the mean score of sore throat was 0.12 in dexamethasone group and 1.12 in

control group at the end of 1 hour after surgery.58

In a study by Sumathi et al, the incidence of

sore throat was significantly less in Betamethasone gel group compared with Lidocaine Jelly

and control group in the first hour.59

In a study by Tabari et al, 20% of the study subjects in

IV Dexamethasone group, 6.6% in the Betamethasone gel group and 14.6% of the subjects in

control group had post-operative sore throat.60

In a study by Kazemi et al, about 78% of the

Betamethasone gel and 46% of the KY jelly group had no sore throat.9 In a study by Teoh et

al, about 51% of the patients in Betamethasone gel group and 39% of the water based jelly

group had sore throat.9 The findings of the later studies are in accordance with the findings of

our study.

At the end of 6 hours, 47.1% of the patients in the Betamethasone gel group had the

minimal sore throat, 25.5% had moderate sore throat and 27.5% of the patients did not have

sore throat at any time since extubation. 20% in the Lidocaine Jelly group had minimal sore

throat, 46% had moderate sore throat, 12% had severe sore throat and 22% did not have any

sore throat since extubation. In the Water based lubricating jelly group 21.2% of the patients

63

had minimal sore throat, 78.8% of the patients had no sore throat at any time since

extubation. In a similar study by Sumathi et al, the incidence of sore throat was least in

Betamethasone gel group when compared to Lidocaine Jelly and control groups.59

In a study

by Tabari et al, 12% of the IV Dexamethasone group, 8% in the Betamethasone gel group

and 25.3% of the control group had post-operative sore throat.60

Our study results correlates

with the study done by Sumathi et al.

At the end of 12 hours, In the Betamethasone gel group 19.6% had minimal sore

throat and 3.9% had moderate sore throat and 76.5% had no sore throat since extubation. In

Lidocaine Jelly group, 18% had minimal sore throat, 12.0% had moderate sore throat, 6% had

severe throat and 64% had no sore throat since extubation .No sore throat was seen at any

time since extubation in the Water based lubricating jelly group.

The Betamethasone gel group had lesser incidence of sore throat compared to

Lidocaine Jelly gel group and control group.59

In a study by Teoh et al, about 28% of the

Betamethasone gel group and 3% of the water based jelly group had sore throat at the end of

12 hours.65

This correlates with our study.

At the end of 24 hours, 7.8% in the Betamethasone gel and 10% in Lidocaine Jelly

group had minimal sore throat. In Lidocaine Jelly group, 4% had moderate sore throat and

6% had severe sore throat. At the end of 24 hours, none of the patients in the Water based

lubricating jelly group had sore throat. In the study by Kiran et al, 16.7% of Lidocaine jelly

group had mild sore throat and 3.3% had moderate sore throat, none had sore throat in

Betamethasone gel group.55

In a study in Jarahzadeh et al, the mean sore throat score was

0.08 in dexamethasone group and 0.62 in the control group.58

In a study by Sumathi et al, the

incidence of sore throat was 100% in the Lidocaine Jelly and control groups and about 40%

in the Betamethasone gel group.59

In a study by Tabari et al, 4% of the IV dexamethasone,

64

none of the betamethasone gel group and 10.6% of the control group had post-operative sore

throat.60

In a study by Kazemi et al, the 86% in the Betamethasone gel group and 54% in the

KY jelly group had no sore throat.9 The incidence of sore throat was 2% in the

Betamethasone gel group and 3% in the water based jelly group .65

Our study shows comparable result with Teoh et al65

where water based lubricating

jelly was more efficient than Lidocaine jelly in prevention of sore throat. In our study

Betamethasone gel, Lidocaine jelly and Water based lubricating jelly were compared, the

results showed Betamethasone gel was better than Lidocaine jelly and the Water based

lubricating jelly showed better result compared to the other two drugs in the prevention of

post-operative sore throat.

Cough

At the end of 1 hour, 45.1% had no cough, 31.4% had minimal cough and 23.5% had

moderate cough in Betamethasone gel group. In Lidocaine Jelly group, 18% had minimal

cough, 38% had moderate cough and 8.0% had severe cough. In the Water based lubricating

jelly group, 94.2% of the patients had no cough and 5.8% had minimal cough. In a study by

Jarahzadeh et al, 4% had cough in the dexamethasone group and 18% in the control group.58

The incidence of cough was around 25% in the Betamethasone gel group, 20% in Lidocaine

Jelly group and over 40% in the control group.59

In a study by Kazemi et al, about 82% of the

Betamethasone gel group and 90% of the KY jelly group had no cough at the end of one

hour.9 In a study by Teoh et al, none of the patients in the Betamethasone gel group and water

based jelly group had cough. Our results have correlation with the study done by Sumathi et

al59

.

At the end of 6 hours, 27.5% of the patients in the Betamethasone gel group had

minimal cough and 15.7% had moderate cough. In Lidocaine jelly group 20% had minimal

65

cough, 34% has moderate cough and 10% had severe cough. In the Water based lubricating

jelly group, 98.1% had no cough and 1.9% had minimal cough or scratchy cough. The

incidence of cough was 5% in Betamethasone gel group, 20% in the Lidocaine Jelly group

and near 40% in the control group in a study by Sumathi et al.59

The later study is in

accordance with the findings of our study.

At the end of 12 hours, 96.1% of the patients of Betamethasone gel group had no

cough and 3.9% had minimal cough. In Lidocaine Jelly group, 76% had no cough, 6% had

minimal cough, 14% had moderate cough and 4% had severe cough. None of the patients of

Water based lubricating jelly group had cough. The incidence of cough was 5% in the

Betamethasone gel group, 40% in the Lidocaine Jelly group and 25% in the control group in

a study by Sumathi et al.59

In a study by Teoh et al, none of the patients in Betamethasone gel

group and control group had cough.65

The results of our study correlates with the study of

Sumathi et al.

At the end of 24 hours, in the Betamethasone gel group, 96.1% of the patients had

no cough at 24 hours, 2% had minimal cough and 2% had moderate cough. In the Lidocaine

Jelly group, 84% had no cough, 6% had minimal cough, 8% had moderate cough and 2% had

severe cough. In the Water based lubricating jelly group, none of the patients had cough at

the end of 24 hours. A study by Jarahzadeh et al, none of the dexamethasone group had

cough at the end of 24 hours and 2% had cough among the controls.58

The incidence of cough

was around 8% in the Betamethasone gel group, over 40% in the Lidocaine Jelly group and

less than 40% in the control group.59

In a study by Kazemi et al, 90% of the Betamethasone

gel group and 64% of the KY jelly group had no cough at the end of 24 hours.9 In a study by

Teoh et al, none of the patients in Betamethasone gel group and control group had incidence

of cough.65

Our results correlates with the study of Teoh et al.

66

Hoarseness

At the end of 1 hour, in Betamethasone gel group, 31.4% had no evidence of

hoarseness at any time since the extubation, 39.2% had no evidence of hoarseness at the time

of interview, 27.5% had the hoarseness at the time of interview noted by patient and 2.0%

had hoarseness that is easily noted at the time of interview. In the Lidocaine Jelly group,

26.0% had no hoarseness since operation, 10% had no evidence of hoarseness at the time of

interview, 36.0% had hoarseness noted by patient and 28% had hoarseness that is easily noted

at interview. 71.2% of the patients in Water based lubricating jelly group had no evidence of

hoarseness since operation, 25.0% had no evidence of hoarseness at the time of interview and

3.8% had hoarseness easily noted at the time of interview. A study by Jarahzadeh et al had

shown that, about 2% in the dexamethasone group and 12% in the control group had

hoarseness.58

The incidence of hoarseness was 3% in Betamethasone gel group, 30% in

Lidocaine Jelly group and 50% in the control group.59

In a study by Kazemi et al, 80% of the

Betamethasone gel group and 40% of the control group had no incidence of hoarseness of

voice.9 In a study by Teoh et al, none of the patients in Betamethasone gel group and control

group had incidence of hoarseness.65

Our study has correlation with the study by Sumathi et

al. with respect to Betamethasone gel in reducing post-operative hoarseness of voice as

compared to Lignocaine jelly.

At the end of 6 hours, in Betamethasone gel group about 37.3% had no evidence of

hoarseness at the time of interview, 25.5% had hoarseness at the time of interview noted by

patient and 2% had hoarseness easily noted at the time of interview. In Lidocaine Jelly group,

20% had no evidence of hoarseness at the time of interview, 34% had hoarseness at the time

of interview noted by patient and 18% had hoarseness that is easily noted at the time of

interview. In Water based lubricating jelly group, 19.2% had no evidence of hoarseness at the

time of interview and 2% had hoarseness at the time of interview. In a study by Sumathi et al,

67

at the end of 6 hours, 3% of the study subjects belonging to Betamethasone gel group, 40% of

the Lidocaine Jelly group and 50% of the control group had hoarseness of voice.59

which

correlates with our study.

At the end of 12 hours, 82.4% had no evidence of hoarseness at any time in

Betamethasone gel group, 13.7% had no evidence of hoarseness and 3.9% had hoarseness at

the time of interview. In Lidocaine Jelly group, 52% had no evidence of hoarseness at any

time, 16% had no evidence of hoarseness at the time of interview, 16% had hoarseness noted

by patient, and 16% had hoarseness that is easily noted at the time of interview. 96.2% had no

evidence of hoarseness at any time and 3.8% had no evidence of hoarseness at the time of

interview in Water based lubricating jelly group. In a study by Jarahzadeh et al, about 2% in

the dexamethasone group and 4% in the control group had hoarseness.58

In a study by

Sumathi et al, at the end of 12 hours, 3% of the Betamethasone gel group, 40% of the

Lidocaine Jelly group and 45% of the control group had hoarseness.59

In a study by Kazemi

et al, 90% of the Betamethasone gel group and 64% of the control group had no hoarseness at

the end of 24 hours.9 At the end of 12 hours none of the patients in Betamethasone gel group

and control group had incidence of hoarseness of voice.65

Our study correlates with the study

of Sumathi et al.

At the end of 24 hours, in the Betamethasone gel group, 3.9% had no evidence of

hoarseness at the time of interview by patient and 5.9% had hoarseness that is easily noted at

the time of interview. In the Lidocaine Jelly group, 2% had no evidence of hoarseness at the

time of interview, 2% had hoarseness at the time of interview noted by patient only and 2%

had hoarseness that is easily noted at the time of interview. In Water based lubricating jelly

group, 5.8% had no evidence of hoarseness at the time of interview. In a study by Kumar et

al, none of the patients had hoarseness at the end of 24 hours in Ketamine, Lidocaine jelly

and control groups.56

In a study in Shaaban et al, the incidence of hoarseness was high in

68

control group compared to Betamethasone gel group and ketamine group.57

In a study by

Jarazadeh et al, the incidence of hoarseness was 2% in dexamethasone group and 4% in

control group.58

In a study by Teoh et al, the incidence of hoarseness was 2% in the

Lidocaine Jelly jelly and nil in KY gel group.65

In a study by Sumathi et al, the incidence of

severe hoarseness of controls was comparable with lidocaine jelly group and Betamethasone

gel group.59

A study by Park SH et al63

showed prophylactic use of 0.2mg/kg of

Dexamethasone significantly reduced the incidence of sore throat and hoarseness of voice at

1hr and 24 hrs after tracheal extubation. Our study results correlates with the results of the

study by Teoh et al.

The local anaesthetic agents such as Lidocaine jelly or spray are known to be


These agents are


in preventing sore throat since they lack anti-inflammatory effects.6

The studies have also


mucosa due to its lubricating properties which supresses the bucking on the tracheal tube.15

The potential mechanism of pain relief in Betamethasone group is presumably based

on its anti-inflammatory activity, which includes inhibition of leukocytes migration

,mainatainence of cell membrane integrity, attenuation of lysosome release ,and reduction of

fibroblast proliferation .A steroid gel applied widely over an endotracheal tube effectively

mitigated post-operative sore throat and hoarseness compared with application of lidocaine

jelly which does not possess any anti-inflammatory activity 63

.

This study was mainly undertaken to test the efficacy of Betamethasone gel,

Lidocaine jelly and Water based lubricating jelly for prevention of post-operative sore throat,

cough and hoarseness of voice. We performed our assessment at 1, 6, 12 & 24 hours post

69

extubation as the mean duration of post-operative sore throat has been suggested as 16+/-11

hour63

.


uncomfortable sequelae after tracheal intubation contributing significantly to the post-

operative morbidity and patient dissatisfaction with their anaesthetic and surgical experience.

The exact cause for post-operative sore throat is not known but factors like irritation and

inflammation of the airway, trauma to the pharyngolaryngeal mucosa, cuff design, contact of

the tracheal tube with vocal cords, cuff form, pressure induced tracheal mucosal capillary

hypo perfusion and pressure over the posterior pharyngeal wall resulting in oedema and

mucosal lesions. Along with these factors sex, age, season, anaesthetic drugs and gases,

number of trials of intubation and duration of intubation contribute to post-operative sore

throat.

Our study revealed that the Water based lubricating jelly (Lubic jelly) when applied over

endotracheal tube during endotracheal intubation was more effective than Betamethasone gel

and Lidocaine jelly in the prevention of post-operative sore throat, cough and hoarseness of

voice.

The limitation of our study was our inability to measure intra-cuff pressures due to non-

availability of the equipment.

70

CONCLUSION

The incidence of post-operative sore throat varies from 44-66%.Although post-operative sore

throat is labelled as minor complications of airway instrumentation, it leads to patients dis-

satisfaction with surgical and anaesthetic experience. The exact aetiology of post-operative

sore throat is not known .Post-operative symptoms are most plausible as a result of mucosal

injury with resulting inflammation caused by the process of airway instrumentation or

irritating effects of foreign objects.

Our study was designed with betamethasone gel which is a steroid with ant-inflammatory

properties, lidocaine jelly a local anaesthetic which have been used in clinical practice and

water based lubricating jelly (Lubic).

In our study 153 patients of both sexes with ASA Grade I and II were enrolled and were

divided randomly into three groups and post operatively these patients were examined and

interviewed for sore throat, cough and hoarseness of voice at 1,6,12 and 24 hour interval. At

all these time intervals water based lubricating jelly group and Betamethasone gel group had

lower incidence of sore throat, cough and hoarseness of voice in comparison to lidocaine

jelly group. Among the Betamethasone gel group and water based lubricating jelly group, the

water based jelly group proved to be more effective in preventing post-operative sore throat,

cough and hoarseness of voice. Hence water based jelly group could be a better lubricating

agent for Endotracheal intubation in comparison with 2% lidocaine jelly group and 0.05%

Betamethasone gel group.

71

SUMMARY

Maintenance of airway is an important aspect in general anesthesia which has advantages

including provision of the reliable airway, prevention of aspiration and smooth delivery

of anaesthetic gases.


uncomfortable sequel after tracheal intubation.A number of pharmacological and non-

pharmacological measures are used for alleviating the postoperative sore throat, cough

and hoarseness of voice with varying degree of success. The application of

Betamethasone gel, Lidocaine jelly and Water based lubricating jelly was tried with

varying degrees of success.

A randomized controlled study was undertaken in the patients posted for elective

surgeries in order to study the efficacy of Betamethasone gel, Lidocaine jelly and water

based lubricating jelly.A total of 153 patients satisfying the inclusion and exclusion

criteria were selected to study the efficacy of three drugs in prevention of post-operative

sore throat, hoarseness of voice and cough.

35.3% of the patients in the Betamethasone gel group, 36.0% in Lidocaine Jelly group

and 38.5% of the Water based lubricating jelly group belonged to 21 – 30 years of age

group. 62.7% of the patients of Betamethasone gel group, 70.0% of the Lidocaine Jelly

group and 65.4% of the patients belonging to Water based lubricating jelly group were

females. In Betamethasone gel group, about 43.1% of the patients had minimal sore

throat, in Lidocaine Jelly group, about 52.0% of the patients had moderate sore throat and

in Water based lubricating jelly group, 67.3% had no sore throat at any time since the

extubation at the end of 1 hour. At the end of 6 hours, about 47.1% of the patients in the

Betamethasone gel group had minimal sore throat, 46.0% in the Lidocaine Jelly group

72

had moderate sore throat and 78.8% in the Water based lubricating jelly group had no

sore throat. At the end of 12 hours, in the Betamethasone gel group 19.6% had minimal

sore throat and 3.9% had moderate sore throat. In Lidocaine Jelly group, 18% had

minimal sore throat, 12.0% had moderate sore throat and 6% had severe throat. At the end

of 24 hours, 7.8% in the Betamethasone gel and 10% in Lidocaine group had minimal

sore throat. In Lidocaine group, 4% had moderate sore throat and 6% in the Water based

lubricating jelly group had severe sore throat. At the end of 24 hours, none of the patients

in the Betamethasone gel group had sore throat.

At the end of 1 hour, 45.1% had no cough, 31.4% had minimal cough and 23.5% had

moderate cough in Betamethasone gel group. In Lidocaine Jelly group, 18% had minimal

cough, 38% had moderate cough and 8.0% had severe cough. In the Water based

lubricating jelly group, 94.2% of the patients had no cough and 5.8% had minimal

cough.At the end of 6 hours, 27.5% had minimum cough and 15.7% had moderate cough

in Betamethasone gel group. 20.0% of the patients in the Lidocaine Jelly group had

minimal cough, 34% had moderate cough and 10% had severe cough. In the Water based

lubricating jelly group, 98.1% had no cough and 1.9% had minimal cough or scratchy

cough. There was no cough at 12 hours in 96.1% of the patients of Betamethasone gel

group and 3.9% had minimal cough. In Lidocaine Jelly group, 76% had no cough, 6%

had minimal cough, 7% had moderate cough and 4% had severe cough. None of the

patients in the Water based lubricating jelly group had cough. In the Betamethasone gel

group, 96.1% of the patients had no cough at 24 hours, 2% had minimal cough and 2%

had moderate cough. In the Lidocaine Jelly group, 84% had no cough, 6% had minimal

cough, 8% had moderate cough and 2% had severe cough.

At the end of 1 hour in Betamethasone gel group, 31.4% had no evidence of hoarseness at

any time since the extubation, 39.2% had no evidence of hoarseness at the time of

73

interview, 27.5% had the hoarseness at the time of interview noted by patient and 2.0%

had hoarseness that is easily noted at the time of interview. In Lidocaine Jelly group 36%

had hoarseness at interview noted by patient and 28% had hoarseness that is easily noted

at the time of interview. In Water based lubricating jelly group 3.8% had hoarseness at

the time of interview noted by the patient only. At the end of 6 hours, in Betamethasone

gel group 37.3% had no evidence of hoarseness at the time of interview, 25.5% had

hoarseness at the time of interview noted by patient and 2% had hoarseness easily noted

at the time of interview. In Lidocaine Jelly group, 20% had no evidence of hoarseness at

the time of interview, 34% had hoarseness at the time of interview noted by patient and

18% had hoarseness that is easily noted at the time of interview. In Water based

lubricating jelly group, 19.2% had no evidence of hoarseness at the time of interview and

2% had hoarseness at the time of interview. At the end of 12 hours, 82.4% had no

evidence of hoarseness at any time in Betamethasone gel group, 13.7% had no evidence

of hoarseness and 3.9% had hoarseness at the time of interview. In Lidocaine Jelly group,

52% had no evidence of hoarseness at any time, 16% had no evidence of hoarseness at

the time of interview, 16% had hoarseness noted by patient, and 16% had hoarseness that

is easily noted at the time of interview. 96.2% had no evidence of hoarseness at any time

and 3.8% had no evidence of hoarseness at the time of interview in Water based

lubricating jelly group.In the Betamethasone gel group, 3.9% had no evidence of

hoarseness at the time of interview by patient and 5.9% had hoarseness that is easily

noted at the time of interview. In the Lidocaine Jelly group, 2% had no evidence of

hoarseness at the time of interview, 2% had hoarseness at the time of interview noted by

patient only and 2% had hoarseness that is easily noted at the time of interview. In Water

based lubricating jelly group, 5.8% had no evidence of hoarseness at the time of interview

at the end of 24 hours.

74

At all these time intervals water based lubricating jelly group and Betamethasone gel

group had lower incidence of sore throat, cough and hoarseness of voice in comparison

to lidocaine jelly group. Among the Betamethasone gel group and water based lubricating

jelly group, the water based jelly group proved to be more effective in preventing post-

operative sore throat, cough and hoarseness of voice. Hence water based jelly group could

be a better lubricating agent for Endotracheal intubation in comparison with 2% lidocaine

jelly group and 0.05% Betamethasone gel group.

75

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ANNEXURES

INFORMED CONSENT FORM

TOPIC: “COMPARISON BETWEEN BETAMETHASONE GEL, LIDOCAINE JELLY

AND LUBRICATING JELLY APPLIED OVER ENDOTRACHEAL TUBE TO REDUCE

POST OPERATIVE SORE THROAT, COUGH AND HOARSENESS OF VOICE”.

I .............................................................................. declare that I have been briefed and

hereby consent to be included as a subject in the following dissertation “COMPARISON

BETWEEN BETAMETHASONE GEL, LIDOCAINE JELLY AND LUBRICATING

JELLY APPLIED OVER ENDOTRACHEAL TUBE TO REDUCE POST OPERATIVE

SORE THROAT, COUGH AND HOARSENESS OF VOICE”. I have been informed to my

satisfaction by the attending doctor, Dr.Srinivasa.B the purpose of the study. This has been

explained to me in the language I understand and I fully consent for the same.

SIGNATURE OF DOCTOR SIGNATURE OF PATIENT/RELATIVE

NAME OF THE DOCTOR NAME

RELATIONSHIP

Date: / / 2013 Date: //2013

Bangalore Bangalore

comparison between betamethasone gel, lidocaine jelly

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