Evaluating the Role of Intratracheal Dexmedetomidine in Post-Extubation Cough Suppression: A one year Hospital-Based Study

Not yet recruiting

Conditions: ASA GRADE I AND ASA GRADE II population

Registration Number: CTRI/2025/05/086166

Lead Sponsor: Sumeet Kaur

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

ASA Grade I and II Patients between age group of 18-60 years Patients undergoing surgery under general anaesthesia with Endotracheal tube.

Exclusion Criteria

Patient allergic to study drug Patients undergoing general anaesthesia with supraglottic airway devices Patient with pre operative sore throat or upper respiratory tract infections.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
To determine the side effects of study drug

Trial Locations

Locations (1): KLES Dr Prabhakar Kore Hospital and Medical Research Centre
🇮🇳
Belgaum, KARNATAKA, India
KLES Dr Prabhakar Kore Hospital and Medical Research Centre
🇮🇳Belgaum, KARNATAKA, India
Sumeet Kaur
Principal investigator
9646240132
sumeet_kaur220@yahoo.co.in