| CTRI Number |
CTRI/2025/03/081994 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To observe postoperative changes in heart rate and blood pressure and cough suppression on giving dexmedetomidine in the tube before taking off the patient from ventilator |
|
Scientific Title of Study
|
Effect of intratracheal Dexmedetomidine to attenuate cardiovascular and airway responses to tracheal extubation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemani Ahuja |
| Designation |
Professor |
| Affiliation |
Christian Medical college and hospital,brown road, ludhiana |
| Address |
Dept. Of Anesthesiology Christian Medical college and hospital,brown road, ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
9501004338 |
| Fax |
|
| Email |
hemaniahuja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Garg |
| Designation |
PG resident Anesthesia |
| Affiliation |
Christian Medical college and hospital,brown road, ludhiana |
| Address |
Dept. Of Anesthesiology Christian Medical college and hospital,brown road, ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
8699924222 |
| Fax |
|
| Email |
priyankagarg6996@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Garg |
| Designation |
PG resident Anesthesia |
| Affiliation |
Christian Medical college and hospital,brown road, ludhiana |
| Address |
Dept. Of Anesthesiology Christian Medical college and hospital,brown road, ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
8699924222 |
| Fax |
|
| Email |
priyankagarg6996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical college and hospital, Brown Road ,Ludhiana, Punjab, India 141008 |
|
|
Primary Sponsor
|
| Name |
Christian Medical college and hospital |
| Address |
Dept. Of Anaesthesia,
1st floor,
Christian Medical college and hospital,brown road, ludhiana, Punjab, India 141008 |
| 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 Hemani Ahuja |
Christian Medical college and hospital |
Department of Anaesthesia, Christian Medical college and hospital , ludhiana punjab
Ludhiana
PUNJAB |
9501004338
hemaniahuja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Christian Medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Group D1- Patient will be administered Dexmedetomidine 0.3 mic/kg diluted till 2 ml with Normal saline intratracheally 30 min before extubation |
| Intervention |
Dexmedetomidine |
Group D2- Patient will be administered Dexmedetomidine 0.5mic/kg diluted till 2 ml with normal saline intratracheally 30 min before extubation |
| Comparator Agent |
Normal Saline |
Group N- patient will be given 2 ml of normal saline intratracheal 30 min before extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-65 years
Patients of ASA grade 1 and 2
Either sex
Patients scheduled for general anaesthesia
|
|
| ExclusionCriteria |
| Details |
Patients with recent upper respiratory tract infections
Patients with uncontrolled or untreated hypothyroidism
Patients with heart disorders like heart block, coronary heart disease
Hepatic and renal insufficiency
Patients on alpha 2 agonist and sedative drugs
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
After instillation of dexmedetomidine intratracheal following parameters will be measured
• Haemodynamic parameters- Heart rate,Blood pressure, SpO2,
•Adverse effects- Hypotension , breath holding, Bradycardia, emergence delirium
|
At the time of instillation of dexmedetomidine , After drug intillation @ 5 min, 10 min, 20 min, 30 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
After extubation following parameters will be measured
• Haemodynamic parameters- Heart rate,Blood pressure, SpO2,
•Adverse effects- Hypotension , breath holding, Bradycardia, emergence delirium
|
1 min before extubation, At extubation, after extubation at 1 min, 5 min, 10 min, 20 min, 30 min |
1. Ramsay sedation score at the time of extubation :
2. Time to reach ramsay sedation score of 3:
3. Time from reversal to extubation:
4. Quality of extubation score :
|
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
22/03/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Introduction: Peri-Extubation cough is an unpleasant event, prevention of which has been studied with multiple pharmacological strategies among which intravenous Dexmedetomidine has emerged as one of the preferred drug. Intratracheal route is attractive as it is easy to use and moreover it avoids hypotension and bradycardia associated with intravenous drug administration. But, there is lack of data exploring the efficacy, dosage and adverse effects of intratracheal Dexmedetomidine. Aims and Objectives : 1.To assess the effectiveness of intratracheal Dexmedetomidine in different doses to attenuate the cardiovascular and airway responses to tracheal extubation. 2.To observe the adverse effects of Dexmedetomidine. Materials and Methods: This study will be conducted on 90 Patients with ASA I and II status scheduled for surgery under general anaesthesia. They will be randomly divided into three groups – Group D1, Group D2, and Group N. 30 minutes prior to extubation these groups will receive intratracheal dexmedetomidine 0.3mic/kg, 0.5mic/kg and 2ml NS respectively. Hemodynamics responses, time taken for extubation, quality of extubation and time to achieve the Ramsay sedation score of 3 will be recorded. |