CTRI Number |
CTRI/2025/05/086166 [Registered on: 02/05/2025] Trial Registered Prospectively |
Last Modified On: |
01/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Evaluating the Role of Intratracheal Dexmedetomidine in Post-Extubation Cough Suppression: A one year Hospital-Based Study |
Scientific Title of Study
|
Evaluation of the effect of low dose intratracheal Dexmedetomidine for attenuation of postextubation cough- A. One year hospital based Randomised Clinical Trial
|
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Sumeet Kaur |
Designation |
Junior Resident |
Affiliation |
JawaharLal Nehru Medical College |
Address |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA 590010
India
Belgaum KARNATAKA 590010 India |
Phone |
9646240132 |
Fax |
|
Email |
sumeet_kaur220@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
Name |
Vandana Gogate |
Designation |
Professor |
Affiliation |
JawaharLal Nehru Medical College |
Address |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA 590010
India
Belgaum KARNATAKA 590010 India |
Phone |
9844083030 |
Fax |
|
Email |
vandanagogate@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Vandana Gogate |
Designation |
Professor |
Affiliation |
JawaharLal Nehru Medical College |
Address |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA 590010
India
KARNATAKA 590010 India |
Phone |
9844083030 |
Fax |
|
Email |
vandanagogate@gmail.com |
|
Source of Monetary or Material Support
|
KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, Karnataka. India. Pincode-590010 |
|
Primary Sponsor
|
Name |
Sumeet Kaur |
Address |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi, Karnataka |
Type of Sponsor |
Other [SELF] |
|
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 |
Sumeet Kaur |
KLES Dr Prabhakar Kore Hospital and Medical Research Centre |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, Karnataka Belgaum KARNATAKA |
9646240132
sumeet_kaur220@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
JNMC Institutional Ethics Committee, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi-590010 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
ASA GRADE I AND ASA GRADE II population |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Intratracheal dexmedetomidine |
The patient would be administered dexmedetomidine 0.3 mcg/kg intra tracheal using Tuberculin syringe (diluted to 2 ml with NS to ensure adequate entry into trachea) via Endotracheal TUBE 10 minutes after intubation . |
Comparator Agent |
Normal Saline |
The patient will recieve 2ml of normal saline intra tracheal 10 minutes after intubation |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ASA Grade I and II
Patients between age group of 18-60 years
Patients undergoing surgery under general anaesthesia with Endotracheal tube.
|
|
ExclusionCriteria |
Details |
Patient allergic to study drug
Patients undergoing general anaesthesia with supraglottic airway devices
Patient with pre operative sore throat or upper respiratory tract infections
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
|
Blinding/Masking
|
|
Primary Outcome
|
Outcome |
TimePoints |
To study the effect of low dose intra tracheal dexmedetomidine on incidence and severity of postextubation cough
|
Immediately after extubation
Every hourly till the first 6 hours
Every 4 hours till 24 hours
|
|
Secondary Outcome
|
Outcome |
TimePoints |
To determine the side effects of study drug
|
After the introduction of the drug till the end of the procedure & continued followup for 24 hours. |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
12/05/2025 |
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="0" 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
|
Intubation with endotracheal tube during general anaesthesia is a fairly common practice in general anaesthesia. Physiological responses are common during anesthesia emergence and endotracheal extubation, causing complications including cough, laryngospasm, bronchospasm, and tachycardia. Studies have shown improvement in post extubation cough with IV Dexmedetomidine but it can have systemic side effects like bradycardia and hypotension. Literature search did not reveal any studies determining the effect of intra tracheal dexmedetomidine on post extubation cough especially in the Indian setting which is why we aim to study the effect of intra tracheal dexmedetomidine on post extubation cough to bypass the systemic side effects. After taking ethical clearance and meeting inclusion and exclusion criteria, patients will be divided into two groups as per computer generated randomisation table. Group A: Will receive 0.3 mcg per kg of intratracheal dexmedetomidine diluted to 2 ml of normal saline Group B: Will receive 2 ml of plain normal saline After a thorough pre operative evaluation, the patient is shifted to recovery and a functional 18G or 20G cannula is secured. Nil by mouth status of the patient is confirmed and the patient is shifted to the operation theatre. Intraoperatively, monitors will be attached and pre operative vitals will be registered. Intraoperative hemodynamic parameters will be monitored. The patient will be premedicated with injection glycopyrrolate 0.005 mg per kg, injection midazolam 0.05 mg per kg, and injection fentanyl 2 mcg per kg. The patient will be induced with injection propofol 2 mg per kg and injection suxamethonium 2 mg per kg. The patient will be intubated with an appropriate size endotracheal tube. After intubation, the cuff will be inflated with an adequate amount of air to prevent leak. Intra cuff pressure will be checked immediately after intubation and then every 30 minutes till end of surgery. The pressure will be maintained at less than 30 cm of water. In Group A, the patient will be administered dexmedetomidine 0.3 mcg per kg intratracheally using a tuberculin syringe (diluted to 2 ml with normal saline to ensure adequate entry into the trachea) via the endotracheal tube 10 minutes after intubation. In Group B, the patient will receive 2 ml of normal saline intratracheally. Following extubation, the incidence and severity of cough will be assessed using a 4 point cough score: Cough score 0 - No cough Cough score 1 - Mild cough (single cough) Cough score 2 - Moderate cough (more than one episode of unsustained cough for less than or equal to 5 seconds) Cough score 3 - Severe cough (sustained bouts of coughing for more than 5 seconds) Cough will be assessed at the following times: Immediately after extubation Every hour till the first 6 hours Every 4 hours till 24 hours
In case of severe cough, the patient will be given antitussive syrup or lozenges on request. |