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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  
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 
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  
Status 
Not Applicable 
 
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.

 
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