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CTRI Number  CTRI/2023/06/053612 [Registered on: 07/06/2023] Trial Registered Prospectively
Last Modified On: 05/06/2023
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   Effect of dexamethasone,ketamine,magnesium sulphate nebulization on attenuation of sore throat,hoarseness of voice and cough in general anaesthesia 
Scientific Title of Study   COMPARISON OF EFFECT OF PRE – OPERATIVE NEBULIZATION WITH DEXAMETHASONE, MAGNESIUM SULPHATE AND KETAMINE ON THE INCIDENCE OF POST OPERATIVE SORE – THROAT AFTER ENDOTRACHEAL INTUBATION IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY: A RANDOMIZED DOUBLE BLIND STUDY. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR MANILA SHARMA 
Designation  SENIOR REGISTRAR 
Affiliation  FORTIS HOSPITAL, MOHALI 
Address  DEPARTMENT OF ANAESTHESIA, FORTIS HOSPITAL, MOHALI

Rupnagar
PUNJAB
160062
India 
Phone  9468407967  
Fax    
Email  manila.manu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR JASMEET KAUR 
Designation  SENIOR CONSULTANT 
Affiliation  FORTIS HOSPITAL, MOHALI 
Address  DEPARTMENT OF ANAESTHESIA, FORTIS HOSPITAL, MOHALI

Rupnagar
PUNJAB
160062
India 
Phone  9781995392  
Fax    
Email  jasmeetkaurdr@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR JASMEET KAUR 
Designation  SENIOR CONSULTANT 
Affiliation  FORTIS HOSPITAL, MOHALI 
Address  DEPARTMENT OF ANAESTHESIA, FORTIS HOSPITAL, MOHALI

Rupnagar
PUNJAB
160062
India 
Phone  9781995392  
Fax    
Email  jasmeetkaurdr@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  FORTIS HOSPITAL, MOHALI 
Address  DEPARTMENT OF ANAESTHESIA, FORTIS HOSPITAL, MOHALI 
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 JASMEET KAUR  FORTIS HOSPITAL, MOHALI  DEPATMENT OF ANAESTHESIA, FORTIS HOSPITAL, MOHALI
Fatehgarh Sahib
PUNJAB 		 9781995392

jasmeetkaurdr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J384||Edema of larynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nebulization with Dexamethasone, Magnesium sulphate and Ketamine.  Nebulization with dexamethasone 2ml (8mg) with 3ml saline, Magnesium sulphate 1ml (250mg) with 4 ml saline and Ketamine 1ml (50mg) and 4 ml Normal Saline and 5ml Normal saline in patients undergoing general anaesthesia with endotracheal intubation, 30 minutes before intubation. 
Comparator Agent  Nebulization with normal saline  Nebulization with normal saline alone. Total volume 5ml in patients undergoing general anaesthesia with endotracheal intubation, 30 minutes before intubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients between 18 to 65 years of either sex undergoing surgery in general anaesthesia in supine position.
2. Duration of surgery upto 2 hours.
3. ASA Grade I and II. 
 
ExclusionCriteria 
Details  1. ASA Grade III and IV.
2. History of recent upper airway infection.
3. Anticipated difficult airway. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To assess the incidence and severity of post operative sore throat.  0, 1, 4 and 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the incidence and severity of post operative hoarseness of voice and cough, hemodynamic parameters and side effects if any.  0, 1, 4 and 24 hours. 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   20/06/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil. 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 03-05-2023 and end date provided 02-05-2030?
    Response - Immediately following publication. No end date.

  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 most common complication in general anaesthesia along with hoarseness of voice and cough. These all maybe considered as a minor complication after surgery and anaesthesia that resolve after few days but it causes discomfort to the patient and decreases the quality of recovery and patient satisfaction. Although symptoms subside without any treatment, the management for POST is still advised. Various pharmacological agents have been used to prevent POST including both intravenous, topical and nebulized drugs. Intravenous agents include steroids, ketamine, magnesium sulphate and lignocaine. Drugs like magnesium sulphate, ketamine, dexamethasone, lignocaine have been used as gargles, topical application on endotracheal tube or nebulization with varying efficacies.
Nebulization is considered better than gargles as it is an easier way to administer the drug, requires a small volume of drug, pungent taste of gargled medication is avoided and is safer method of drug delivery.
 
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