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CTRI Number  CTRI/2025/01/079384 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   a clinical study comparing the effectiveness of dexamethasone and magnesium sulphate versus placebo in preventing post-operative sore throat (POST) following endotracheal intubation. 
Scientific Title of Study   Comparative placebo controlled study of dexamethasone and Magnesium sulphate in preventing post operative sore throat Following endotracheal intubation  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chiteshwar Walia 
Designation  Associate Professor 
Affiliation  Sri Guru Ram Das Institute of Medical Sciences and Research 
Address  Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar

Amritsar
PUNJAB
143001
India 
Phone  9878339933  
Fax    
Email  chiteshwarwalia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Geetanjali 
Designation  Associate Professor 
Affiliation  Sri Gur Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar 
Address  Main OT, Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar

Amritsar
PUNJAB
143001
India 
Phone  9872981079  
Fax    
Email  gitzgitz@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Balkaran Sher Singh 
Designation  Junior Resident 
Affiliation  Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar 
Address  Main OT, Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar

Amritsar
PUNJAB
143001
India 
Phone  9878312631  
Fax    
Email  shersinghbalkaran@gmail.com  
 
Source of Monetary or Material Support  
Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, India, 143001 
 
Primary Sponsor  
Name  SGRD 
Address  Main OT, Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar. 143001 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Ruchi Gupta  SGRD  OT 2 and 3, Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar
Amritsar
PUNJAB 		 09814020805

drruchisgrd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SGRD Ethical Committee  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 
Intervention  Nebulisation  Pre Operative nebulisation for prevention of postoperative sore throat following endotracheal intubation 
Comparator Agent  nebulised with 5ml of normal saline.  Group A: Will be nebulised with dexamethasone 8mg [2ml] with 3ml of normal saline.  
Comparator Agent  nebulised with 5ml of normal saline.  Group B: Will be nebulised with MgSo4 [50% W/V 2ml] with 3ml of normal saline. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I & II
Modified Mallampatti Score 1-2. 
 
ExclusionCriteria 
Details  1.Patients who needed more than two attempts at endotracheal intubation
and use of bougie and styllete
2. Patients with history of sore throat
3. Long term anti-inflammatory analgesic medications
4. Patients who have undergone insertion of devices which stimulate oral
cavity, larynx, pharynx like nasogastric tube
5. Obese, diabetic, pregnant patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of Dexamethasone versus Magnesium
sulphate against placebo in preventing POST following endotracheal intubation 		 at the time of start of surgery, 4 hours, 8 hours and 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To Compare the frequency and severity of post operative sore throat among the patients in
each group 		 Patients will be assessed postoperatively at 0 hour, 4hr, 8hr 24th hour 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   20/12/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Introduction: Post-operative sore throat is a common complication following endotracheal intubation, impacting patient comfort and recovery. Dexamethasone and magnesium sulfate have been studied for their potential to mitigate this issue, yet their comparative effectiveness against a placebo remains to be comprehensively evaluated. 

Objective: This study aims to compare the efficacy of dexamethasone and magnesium sulfate, each against a placebo, in preventing post-operative sore throat following endotracheal intubation.

Methods: A randomized, placebo-controlled trial will be conducted among patients undergoing surgeries requiring endotracheal intubation. Participants will be randomly assigned to receive dexamethasone, magnesium sulfate, or placebo preoperatively. Post-operative sore throat severity will be assessed using a standardized scoring system, along with monitoring of adverse effects. 

Outcome: This study will provide effectiveness of dexamethasone and magnesium sulfate compared to placebo in preventing post-operative sore throat, contributing to optimized perioperative management strategies. 

Conclusion: Findings from this study will inform clinical practice regarding the use of different interventions to reduce post-operative sore throat incidence following endotracheal intubation, potentially improving patient outcomes. 
 
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