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CTRI Number  CTRI/2021/09/036526 [Registered on: 15/09/2021] Trial Registered Prospectively
Last Modified On: 11/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   to study the effect of nebulized Dexmedetomidine and Dexamethasone in preventing sore throat following endotracheal intubation  
Scientific Title of Study   Comparative study of nebulized Dexmedetomidine and Dexamethasone in preventing sore throat following endotracheal intubation  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gurpreeti Grewal 
Designation  Associate Professor Anaesthesia 
Affiliation  Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India

Ludhiana
PUNJAB
141001
India 
Phone  9779552017  
Fax    
Email  grewal.preeti@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Livleen Deep Mann 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India

Ludhiana
PUNJAB
141001
India 
Phone  8360133496  
Fax    
Email  lavinamann30@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gurpreeti Grewal 
Designation  Associate Professor Anaesthesia 
Affiliation  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India

Ludhiana
PUNJAB
141001
India 
Phone  9779552017  
Fax    
Email  grewal.preeti@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital,Tagore nagar,Civil Lines Ludhiana 141001 Punjab 
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital 
Address  Dayanand Medical College and Hospital,Tagore nagar,Civil Lines Ludhiana 141001 Punjab  
Type of Sponsor  Private 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 
Dr Gurpreeti Grewal  Dayanand Medical College and Hospital   Anaesthesia department
Ludhiana
PUNJAB 		 9779552017

grewal.preeti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethical Committee Dayanand Medical College and Hospital Civil Lines Ludhiana   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, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Preoperative nebulization  Patients will receive nebulized dexamethasone 8ml with 3 ml of normal saline, 15 minutes prior to induction  
Comparator Agent  Preoperative nebulization  Patients will receive nebulized Dexmedetomidine 50ug with 4.5 ml of normal saline 15 minutes prior to induction  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  ASA I, II and III patients with age group of ≥18 years undergoing surgery under general anaesthesia with endotracheal intubation. 
 
ExclusionCriteria 
Details  1.History of recent upper respiratory tract infection or sore throat
2.Duration of surgery >3 hrs
3.Mallampati grade ≥3
4.Patients who will need more than one intubation attempt
•Patient allergic to the drugs used in the study.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare role of nebulized Dexmedetomidine with Dexamethasone in preventing Post Operative Sore Throat following endotracheal intubation.   Immediate postoperatively till 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To assess any other side effects (if any)   24 hours 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   15/09/2021 
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="2"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published 
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 - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [lavinamann30@gmail.com].

  6. For how long will this data be available start date provided 14-11-2023 and end date provided 14-11-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Post operative sore throat is experienced by patients during the post operative recovery period following general anaesthesia with endotracheal intubation. Nebulized Dexmedetomidine and Dexamethasone are being used in preventing post operative sore throat but very limited studies have been done to compare the effect of two drugs. Our aim in this study is to compare the effectiveness of nebulized Dexmedetomidine with Dexamethasone in preventing post operative sore throat. A total of 150 patients will be randomly allocated to either of three study groups of 50 patients of either sex each;.≥18 years ; ASA  I-III, undergoing surgery under general anaesthesia with endotracheal intubation will be included in this prospective,double blind ,randomized controlled trial. Exclusion criteria is patients with history of recent upper respiratory tract infection or sore throat ,duration of surgery >3 hrs, Mallampati grade ≥3 , patients who need more than two intubation attempts, patient allergic to the drugs used in the study. Patients will be divided into three groups of 50 each ,group a and b are nebulized with Dexmedetomidine and Dexamethasone respectively, group C is control and patients in this group are nebulized with normal saline. Patients will be assessed in the postoperative ward by an anaesthesiologist blinded for the study. Intensity of sore throat, cough, hoarseness and pain will be assessed at 0 hr, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, 24 hr postoperatively. The severity of POST will be graded. The data thus obtained will be compiled and analysed to reach valid conclusions. 
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