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CTRI Number  CTRI/2024/01/061491 [Registered on: 15/01/2024] Trial Registered Prospectively
Last Modified On: 25/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A comparative study of efficacy of preoperative Dexmedotimidine nebulization with Magnesium sulphate nebulization in reducing post operative sore throat in patients undergoing general anaesthesia 
Scientific Title of Study   A comparative study of efficacy of preoperative Dexmedotimidine nebulization with Magnesium sulphate nebulization in reducing post operative sore throat in patients undergoing general anaesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sindhu N Pawadigoudra 
Designation  MBBS 
Affiliation  Mysore medical college and research institute 
Address  MMCRI PG girls hostel Opposite Nanjaraj Choultry Vinoba road MYSURU

Mysore
KARNATAKA
570001
India 
Phone  8150802056  
Fax    
Email  sindhunp1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sindhu N Pawadigoudra 
Designation  MBBS 
Affiliation  Mysore medical college and research institute 
Address  MMCRI PG girls hostel Opposite Nanjaraj Choultry Vinoba road MYSURU

Mysore
KARNATAKA
570001
India 
Phone  8150802056  
Fax    
Email  sindhunp1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sindhu N Pawadigoudra 
Designation  MBBS 
Affiliation  Mysore medical college and research institute 
Address  MMCRI PG girls hostel Opposite Nanjaraj Choultry Vinoba road MYSURU

Mysore
KARNATAKA
570001
India 
Phone  8150802056  
Fax    
Email  sindhunp1@gmail.com  
 
Source of Monetary or Material Support  
KR Hospital, Irwin road, Devaraj Mohalla, Yadavgiri, Mysore, Karnataka - 570001 
 
Primary Sponsor  
Name  Department of Anaesthesiology  
Address  Mysore medical college aand research institute. Mysuru, Karnataka - 570001 
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 
Sindhu N P  New stone building   K R Hospital Irwin road Mysore 570001
Mysore
KARNATAKA 		 8150802056

sindhunp1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Instititional Ethics Committee  Approved 
Instititional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group D  Dexmeditomidine 1mcg/kg body weight in 4 ml normal saline for 15 min 
Intervention  Group M  Magnesium Sulphate 250 mg in 4 ml normal saline for 15 min 
Comparator Agent  Groupo c  Nebulized normal saline for 5 minutes  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All ASA grade I and grade II patients between 19 to 60 years of age group of both sexes
Mallampati grade 1 and 2
duration of surgery less than 2 hours
Body mass index 25 to 30 kg/m2
Elective surgeries under general anasesthesia with endotracheal intubation and controlled ventilation 
 
ExclusionCriteria 
Details  Age <18 yeras and >60 years
ALL ASA Grade III and above
Mallampati grade III and above
Patients with URTI, LRTI, Asthma, COPD, Smoking
Difficult airway, who need nasogastric tube insertion.
Head and Neck surgeries, Emergency surgeries
Patients who require more than one attempt of intubation and in whom the time taken for intubation is more than 20s 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Post Operative Sore Throat
Present or Absent
If present Grade 0 to 3 		 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse effects likenausea, vomiting, dry mouth, sedation  0hr, 2hr, 6hr, 12hr, 24hrs 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   27/01/2024 
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="1"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

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

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

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sindhunp1@gmail.com].

  6. For how long will this data be available start date provided 25-12-2024 and end date provided 25-12-2030?
    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   This is a comparative study of preoperative Dexmedotimidine nebulization with Magnesium sulphate nebulization in reducing post operative sore throat in patients undergoing general anaesthesia for elective surgeries in KR Hospital, Mysuru. 
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