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CTRI Number  CTRI/2024/06/068918 [Registered on: 14/06/2024] Trial Registered Prospectively
Last Modified On: 12/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Prevention of postoperative sore throat 
Scientific Title of Study   Comparison of Nebulised Dexmedetomidine, Magnesium sulphate And Dexamethasone in Prevention of Postoperative Sore throat After Tracheal Intubation in Adults: A Double-blind Randomized Control Study  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dinesh S 
Designation  Anaesthesia Academic Junior Resident 
Affiliation  AIIMS Patna 
Address  C5B,Department of Anaesthesiology,5th floor,IPD complex,AIIMS Patna,Phulwari Sharif,Patna ,BIHAR 801507,India

Patna
BIHAR
801507
India 
Phone  9629751584  
Fax    
Email  dineshsn2000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Neeraj Kumar 
Designation  Associate Professor 
Affiliation  AIIMS Patna 
Address  Room No 505,Department of Anaesthesiology,B Block OT complex,Aiims Patna,Phulwari Sharif,Patna,BIHAR 801507,India

Patna
BIHAR
801507
India 
Phone  8210104972  
Fax    
Email  neeraj.jlnmc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Neeraj Kumar 
Designation  Associate Professor 
Affiliation  AIIMS Patna 
Address  Room No 505,Department of Anaesthesiology,B Block OT complex,Aiims Patna,Phulwari Sharif,Patna,BIHAR 801507,India

Patna
BIHAR
801507
India 
Phone  8210104972  
Fax    
Email  neeraj.jlnmc@gmail.com  
 
Source of Monetary or Material Support  
All India institute of medical sciences patna, Phulwari Sharif,Bihar 801507,India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Patna 
Address  Department of Anaesthesiology, B Block OT Complex,AIIMS Patna,Bihar 801507,India 
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 Neeraj Kumar  All India Institute of Medical Sciences Patna  Department of anaesthesiology Office C5B Area, 5th floor B-Block ,IPD Complex AIIMS Patna
Patna
BIHAR 		 08210104972

neeraj.jlnmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,AIIMS Patna  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  Nebulization with Dexamethasone  Ultrasonic nebulization of 0.1mg/kg Dexamethasone in volume of 4 ml 
Intervention  Nebulization with Dexmedetomidine  Ultrasonic nebulization of 0.5mcg/kg dexmedetomidine diluted in volume of 4 ml 
Intervention  Nebulization with Magnesium sulphate  Ultrasonic nebulization of 30mg/kg magnesium sulphate in a volume of 4 ml 
Comparator Agent  Nebulization with Normal saline  Ultrasonic nebulization of 0.9% Normal saline in volume of 4 ml 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing surgeries with tracheal intubation lasting for more than 1 hour and less than 2 hours
ASA PS I and II
Adult normotensive patients 
 
ExclusionCriteria 
Details  Patient refusal
Patients allergic to any of the study drugs
Patient with any upper respiratory tract infection
Patients with anticipated difficult intubation
ASA PS III and IV (Uncontrolled Diabetes)
Patients requiring more than 15 seconds of intubation
Two attempts of laryngoscopy or more 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Compare the incidence of Post Operative Sore throat within 24 hours of tracheal extubation.

 		 0 hour
30 minutes
4 hours
24 hours

 
 
Secondary Outcome  
Outcome  TimePoints 
To measure the severity of Post Operative Sore throat (Moderate & Severe) by using a standard scoring system.
 		 0 hour
30 minutes
4 hours
24 hours 
To note any other laryngeal complications such as cough, or hoarseness of voice observed within 24 hours of tracheal extubation.

 		 0 hour
30 minutes
4 hours
24 hours 
To find out any difference in systolic, diastolic & Mean arterial Blood pressure changes from baseline.
 		 0 minutes of intubation
2 minutes of intubation
4 minutes of intubation
6 minutes of intubation 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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)   25/06/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [neeraj.jlnmc@gmail.com].

  6. For how long will this data be available start date provided 20-06-2024 and end date provided 20-07-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Post-operative sore throat (POST) is one of the undesirable outcomes that occurs in patients following General anesthesia with endotracheal intubation. The incidence of POST varies from 14% to 50% following endotracheal intubation. Several risk factors have been identified for developing POST following endotracheal intubation including obesity, female sex, size of endotracheal tube, prolong duration of surgery, multiple intubation attempts, emergency intubation in intensive care unit (ICU). The intubation technique results in pathological changes including epithelial loss, glottic oedema, submucosal tears, and contact ulcer granuloma, which play an important role in POST development . Although it is self-limiting, it needs to be prevented because it seriously affects patient satisfaction and postoperative recovery. Despite the emergence of clinical trials on POST nebulization therapy, still no current overview of all the relevant drugs.Even there is lack of direct comparisons of these frequently used aerosolized drugs and lack of a clinically useful ranking of all atomizing drugs concerning both efficacy and acceptability. So in this study comparison between Nebulized Dexmedetomidine, Nebulized Magnesium sulphate and Nebulized Dexamethasone may be equally effective in the prevention of POST. 
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