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CTRI Number  CTRI/2025/10/096174 [Registered on: 17/10/2025] Trial Registered Prospectively
Last Modified On: 17/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing 2 drugs in reducing coughing response during endotracheal extubation: A controlled study 
Scientific Title of Study   Comparison between clonidine and dexmedetomidine in suppressing cough response during tracheal extubation : A controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NiIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Navya S U 
Designation  Postgraduate student  
Affiliation  M S Ramaiah Medical College 
Address  Department of Anaesthesiology, M S Ramaiah Medical College, MSRIT post, New BEL Road, Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9739759378  
Fax    
Email  navyasu123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Leena H Parate 
Designation  Professor  
Affiliation  M S Ramaiah Medical College and Hospital 
Address  Department of Anaesthesiology, M S Ramaiah Medical College, MSRIT post, New BEL Road, Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9480525925  
Fax    
Email  dr_leenag@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Leena H Parate 
Designation  Professor  
Affiliation  M S Ramaiah Medical College and Hospital  
Address  Department of Anaesthesiology, M S Ramaiah Medical College, MSRIT post, New BEL Road, Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9480525925  
Fax    
Email  dr_leenag@yahoo.co.in  
 
Source of Monetary or Material Support  
M S Ramaiah Medical College and Hospital 
 
Primary Sponsor  
Name  M S Ramaiah Medical College  
Address  MSRIT post, New BEL Road, Bangalore, 560054 
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 Navya S U  M S Ramaiah Medical College Hospital  Department of Anaesthesiology, M S Ramaiah Medical College, MSRIT post, New BEL Road, Bangalore - 560054
Bangalore
KARNATAKA 
9739759378

navyasu123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ramaiah Medical College Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 3||Administration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Clonidine  Patients receive 0.75mcg/kg of Clonidine diluted upto 100ml NS, given over 10 minutes before extubation 
Intervention  Dexmedetomidine  Patients receive 0.5mcg/kg of Dexmedetomiidine diluted upto 100ml NS, given IV over 10 minutes before extubation 
Comparator Agent  Normal Saline  Patients receive plain NS IV over 10 minutes before extubation  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologists physical status 1 and 2 
 
ExclusionCriteria 
Details  1. Pregnant and lactating mothers
2. Severe cardiovascular, renal or hepatic disorders
3. People who are allergic to the study drugs
4. Patients with anticipated difficult airway
5. Patients who are already on study drugs
6. Patients with any respiratory diseases 
 
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 
Cough score   During extubation  
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic responses  During extubation  
Sedation score  During extubation  
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   28/10/2025 
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="2"
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 - NO
Brief Summary  

Tracheal extubation is a very crucial event in the course of general anaesthesia. The Difficult Airway Society has given guidelines for successful extubation but there is no uniform consensus regarding criteria for smooth extubation1.  Extubation causes reflex sympathetic discharge due to epipharyngeal and laryngopharyngeal stimulation. While strategies to blunt intubation response are very well studied, there is very little information on the process of smooth extubation. Smooth tracheal extubation is defined as no gross purposeful muscular movement, such as coughing, within 1 minute of tracheal tube removal. 

     Extubation stress response can be deleterious as it can cause   hypertension, tachycardia and exaggerated airway reflexes  A few of the drugs have been studied for prevention and treatment of these undesirable effects such as opioid analgesics, local anaesthetics like Lignocaine, Ketamine, and Dexmedetomidine. The centrally acting highly selective alpha-2 agonists Dexmedetomidine and Clonidine have sympatholytic, analgesic, sedative properties without any effect on respiration. 

b. Need for the study: 

     There is paucity in the literature about the process of conducting smooth extubation, especially with clonidine. Considering this, the study is aimed to compare the effectiveness of Clonidine and Dexmedetomidine in evaluating cough score in patients undergoing elective surgeries under General Anaesthesia

 
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