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CTRI Number  CTRI/2021/10/037147 [Registered on: 07/10/2021] Trial Registered Prospectively
Last Modified On: 06/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Other 
Public Title of Study   A comparative evaluation between giving dexamethasone in aerosol form and magnesium sulphate in aerosol form and assessing whether it prevents post operative sore throat in patients undergoing surgeries under general anaesthesia 
Scientific Title of Study   A Comparative study of efficacy of dexamethasone and MgSO4 preoperative nebulisation in reduction of postoperative sore throat following general anaesthesia  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manoj singh kunwar 
Designation  Post Graduate 
Affiliation  Government medical college ,haldwani ,nainital ,uttarakhand 
Address  DEPARTMENT OF ANAESTHESIA,GOVERNMENT MEDICAL COLLEGE, Haldwani, Distt. Nainital, Uttarakhand.

Nainital
UTTARANCHAL
263139
India 
Phone  7456914657  
Fax    
Email  mskunwar5375@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR AJAY KUMAR SINHA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Government medical college ,haldwani ,nainital ,uttarakhand 
Address  DEPARTMENT OF ANAESTHESIA,GOVERNMENT MEDICAL COLLEGE, Haldwani, Distt. Nainital, Uttarakhand.

Nainital
UTTARANCHAL
263139
India 
Phone  9897672301  
Fax    
Email  drajayksinha@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Manoj singh kunwar 
Designation  Post Graduate 
Affiliation  Government medical college, Haldwani,nainital,uttarakhand 
Address  DEPARTMENT OF ANAESTHESIA ,GOVERNMENT MEDICAL COLLEGE, Haldwani, Distt. Nainital, Uttarakhand.

Nainital
UTTARANCHAL
263139
India 
Phone  7456914657  
Fax    
Email  mskunwar5375@gmail.com  
 
Source of Monetary or Material Support  
GMC haldwani, distt nainital uttarakhand 
 
Primary Sponsor  
Name  GMC haldwani 
Address  GMC,Rampur Road,Haldwani, Distt. nainital, Uttarakhand 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Manoj singh kunwaR  SUSHILA TIWARI GOVERNMENT HOSPITAL  Department of anaesthesiology, GOVERNMENT MEDICAL COLLEGE, Haldwani,NAINITAL UTTARAKHAND
Nainital
UTTARANCHAL 		 7456914657

mskunwar5375@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, GOVERNMENT MEDICAL COLLEGE, haldwan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DEXAMETHASONE  DEXAMETHASONE IS A LONG ACTING SYNTHETIC DERIVATIVE OF CORTISOL. it is very helpful in relieving post.aerosol route Group A will receive nebulization with 8 mg dexamethsone in 5 ml of NS preoperatively before induction of anaesthesia and assesing laryngoscopy response, intraoperative hemodynamic in first 5 10 15 mins respectively and evaluating sore throat in post op period 
Comparator Agent  MAGNESIUUM SULPHATE  magnesium sulphate is a NMDA receptor antagonist with local analgesic and anti inflammatory effects.Aerosol route Mgso4 250 mg in normal saline making total 5 ml given preoperatively before induction of anaesthesia and assessing laryngoscopy response , intraoperative hemodynamics in first 5 10 15 mins respectively and evaluating sore throat in post op period. 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1- Patients belonging to ASA physical status – Grade I and II.
2- Surgeries under general anaesthesia following endotracheal intubation.
3- Duration of surgery less than 3 hours.
 
 
ExclusionCriteria 
Details  1. Patient / guardian refusal for consent.
2. Patients having history of preoperative sore throat or recent upper airway infection,asthma ,chronic obstructive pulmonary disease
3. History of allergy to proposed/used drugs in the study.
4. Pregnant women.
5. Mallampati grade > II ( anticipated difficult airway )
6. Patients on chronic medication(NSAID,STEROIDS)
7. Patients requiring more than one attempt at intubation or traumatic intubation.
8. Known smoker.
9. Time of intubation greater than 60 seconds.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of pre operative nebulisation of dexamethasone versus mgso4 on incidence of POST  sore throat will be assessed at 0 hr, 4 hr, 6 hr, 24 hr 
 
Secondary Outcome  
Outcome  TimePoints 
To grade the severity of POST between the two groups.
To compare changes in hemodynamics and any related side-effects among groups. 		 INTRAOPERATIVELY AT TIME 0 MIN 5 MIN 10 MIN AND 15 MIN AFTER INTUBATION RESPECTIVELY 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/10/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Title:

A comparative Study of efficacy of Dexamethasone and Mgso4 preoperative nebulisation in reduction of post operative sore throat following general anaesthesia.

INTRODUCTION

 

Sore throat is one of the most common postoperative complaints, which lead to postoperative morbidity and patient dissatisfaction. It is 5th most frequent adverse clinical anaesthesia outcome with reported incidence upto 21%-65%  Postoperative sore throat (POST) depends upon a multitude of factors which include but are not limited to gender, age of the patient, number of attempts and manipulation required to place the endotracheal tube (ETT), ETT cuff pressure and size, total duration of endotracheal tube in trachea and suctioning attempts.  Irritation and inflammation of the airway, mechanical injury during intubation, damage to the mucosa due to the pressure from the endotracheal tube cuff and dehydration of the mucosa were considered the cause of postoperative sore throat (POST)   Active management for POST is advised because it enhances patient satisfaction, acceptance of anaesthesia and improves the activities after discharge. Although symptoms subside even without any treatment, if left untreated, the patient will have a longer stay in post anaesthesia care and discharged later, as compared to those who did receive treatment or those who did not complain of POST. 

                  Different agents like ketamine gargle and nebulisation, endotracheal tube spraying with beclomethasone,intravenous injection of dexamethasone , magnesium sulphate gargle  and Lozenges, nebulized lignocaine , lignocaine jelly have been used with variable success for decreasing both the incidence and severity of POST. Corticosteroids are used in the perioperative period to enhance the effects of analgesics and antiemitics. Inhaled carticosteroids deliver the drug to the airways without systemic effects.

Dexamethasone is a long acting, synthetic derivative of cortisol (hydrocortisone); with chemical structure 1-dehydro-9α-fluoro-16α-methylhydrocortisone. It is an agonist of the glucocorticoid receptor.

Chemical structure of dexamethasone

 

 

 

 

 

Dexamethasone is a potent steroid that has 26.6 and 6.6 times stronger anti-inflammatory and immune-suppressant effects than cortisol and prednisone, respectively. It has been supported that it is very useful for relieving POST. Therefore, inhaling dexamethasone may be used as a method to reduce POST following general anesthesia.

Magnesium sulphate is a magnesium salt having sulphate as the counterion. It has a role as an anticonvulsant, a cardiovascular drug, a calcium channel blocker, an anaesthetic, a tocolytic agent, an anti-arrhythmia drug and an analgesic.

Chemical structure of Magnesium Sulphate

 

 

 

 

 

Magnesium sulphate is a N-Methyl-D-Aspartate (NMDA) receptors antagonist with local analgesic and anti-inflammatory effects NMDA receptors antagonists are found in central and peripheral nervous system. Magnesium Sulphate is administered as gargles, lozenges or nebulisation before surgery for control of postoperative sore throat (POST). The nebulized route ensures equivalent and effectual distribution of magnesium sulphate all over the pharynx till the beginning of the upper respiratory tract.

 

 

 

 

REVIEW OF LITERATURE

        Kamel et al. in 2020 studied the effect of preoperative nebulized: Magnesium sulfate versus lidocaine on the prevention of post intubation sore throat . They concluded that the  preoperative 250 mg nebulized magnesium sulfate has more protection against post-intubation sore throat than 100 mg nebulized lidocaine lasting up to 24 h after the operation.

       Kumari et al in 2019 compared the efficacy of nebulized dexamethasone versus ketamine in preventing POST. They concluded that  pre-operative single dose of nebulized dexamethasone 8 mg effectively attenuates POST in patients following general anaesthesia with endotracheal intubation compared to nebulized ketamine 50 mg without any detrimental effects.

      Mostafa et al in 2018 studied comparatively three Nebulized Medications for the prevention of postoperative Sore Throat in the pediatric population. They concluded that the  preoperative nebulization with ketamine was more effective in reducing the intensity of POST in pediatric patients postoperatively without systemic adverse effects.

      Reddy et al in 2018 studied Dose-dependent effectiveness of ketamine nebulisation in preventing postoperative sore throat due to tracheal intubation. They concluded that the Nebulized ketamine is well accepted by all patients and effective in reducing the severity of post-operative sore throat without any untoward effects. However larger population studies and estimation of serum ketamine levels is needed to find out a better dose of ketamine for nebulization to prevent the incidence and severity of post-operative sore throat.

     Mehrotra et al in 2017 conducted an experimental, randomized, double- blind study to compare the effectiveness of preoperative nebulisation with ketamine, budesonide and lignocaine in reducing the incidence and severity of post operative sore throat. They concluded that the nebulisation with lignocaine was efficacious in reducing cough and ketamine reduced sore throat in early post operative period ,whereas long term outcome was better with budesonide.

      Jain et al in 2017 conducted a Comparative Study of Preoperative Ketamine and MgSO4 Nebulisation for Incidence of Post Operative Sore Throat after Endotracheal Intubation. They concluded that the coincidence of sore throat was significantly less with ketamine and MgSO4 nebulisation. 

       

                                                                        

 

 AIM

 

To compare the efficacy of  Dexamethasone and MgSO4 pre operative nebulisation for reduction of post operative sore throat.

 

OBJECTIVES

 

Primary objective-

 

To compare the effect of preoperative nebulisation of dexamethasone versus magnesium sulfate  on the incidence and severity of  POST .

 

Secondary objective-

 

To grade the severity of POST between the two groups.

 

To compare changes in hemodynamics and any related side-effects among groups.

 

 

 

 

 

 

 

 

 

 

MATERIALS AND METHODS

 

STUDY DESIGN:  A  Prospective comparative study.

PLACE OF STUDY:  Dr. Sushila Tiwari Government Hospital, Haldwani .

PERIOD OF STUDY:  January 2021 to September 2022.

SAMPLE SIZE

 

Assuming incidence of POST is 65% from earlier studies and to achieve a 50% reduction in the incidence at alpha = 0.05, confidence interval 95% and power = 90% , the minimum amount of sample required for the study is 30 patients per group. 10% drop out compensation increase the sample size to 40 patients per group.

 

SAMPLING TECHNIQUE

 

Patients who fulfill the inclusion criteria and do not have any exclusion criteria , will be randomly divided into two groups , Group A and Group B using computer generated random numbers.

·         Group A -  receive nebulization with 8 mg dexamethsone in 5 ml of NS.

·         Group B - receive nebulization with 250 mg magnesium sulphate in 5 ml of NS.

 

INCLUSION CRITERIA

  1. Both male and female
  2. Patients belonging to ASA  physical status – Grade I and II.
  3. Age between 20 to 60 years.
  4. Surgeries under general anaesthesia following endotracheal intubation.
  5. Duration of surgery less than 3 hours.

 

 

 

 

EXCLUSION CRITERIA

  1. Patient / guardian refusal for consent.
  2. Patients having history of preoperative sore throat or recent upper airway infection,asthma ,chronic obstructive pulmonary disease
  3.  History of allergy to proposed/used drugs in the study.
  4. Pregnant women.
  5. Mallampati grade > II ( anticipated difficult airway )
  6. Patients on chronic medication(NSAID,STEROIDS)
  7. Patients requiring more than one attempt at intubation or traumatic intubation.
  8. Known smoker.
  9. Time of intubation greater than 60 seconds.

 

 

 

 

 

 

 

 

 

 

METHODOLOGY

After institutional and ethical committee approval and written informed consent, patients undergoing surgery under general anaesthesia with endotracheal intubation for elective surgery will be included in the study. Patients who fulfill the inclusion criteria and do not have any exclusion criteria, will be randomly divided into two groups, Group A and Group B using computer generated random numbers. All patients will be kept fasting overnight and will be premedicated with oral ranitidine 150mg, perinom 10 mg andlorazepam 1 mg on night before surgery and on the morning of surgery.On arrival to operation theatre all patients will be  secured an iv line with 18 G cannula on non dominant hand and maintenance iv fluids will be started ASA(American society of anesthesiologists) standard monitors like electrocardiogram (ECG), non invasive blood pressure (NIBP), and end tidal carbon dioxide (ETCO2) monitoring will be attached and baseline parameters like heat rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and oxygen saturation (SPO2) will be noted prior to nebulization , post nebulization and pre induction .Before giving general anaesthesia , patients will be receiving nebulization of the study drug for 10 minutes with wall mounted oxygen source at 10 litres /min (50 psi pressure ) . The study drug will be prepared by an anaesthetist who is not part of the study.Group A will receive nebulization with 8 mg dexamethsone in 5 ml of NS. Group B will receive nebulization with 250 mg magnesium sulphate in 5 ml NS. Upon arrival to PACU (post anaesthesia care unit ) patient will be assessed regarding the incidence and severity of POST at 0 hour. The incidence and severity of POST will be assessed from the patients by asking the presence or absence of soarness in the throat and patients who experiences any degree of throat pain will be considered as having sore throat.

 

 

Parameters  to be studied-

 

Patient will be assessed post operatively at zero hour,4th hour,6th hour, and 24th hour.

Sore throat is defined as continous throat pain.

Hoarseness is defined as abnormal voice change.

Cough is defined as a sudden noisy explusion of air from the lungs.

The severity of POST will be assessed by a four point scale(0-3) as follows

 

 

 

STATISTICAL ANALYSIS

 

Data will be analysed using appropriate statistical techniques.


 
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