| 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
|
|
|
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
|
|
|
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 |