A CLINICAL TRIAL TO STUDY COMPARISION OF 1 VS 2µg/kg OF DEXMEDETOMIDINE NEBULISATION PRE-OPERATIVELY FOR BLUNTING HAEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND INTUBATION

Not yet recruiting

• Conditions: External causes of morbidity, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2021/09/036747
• Lead Sponsor: Dayanand Medical College and Hospital

Brief Summary

Dexmedetomidine, a potent, highly selective alpha-2 adrenergic receptor agonist have been used for blunting haemodynamic response to laryngoscopy and intubation through IV, intranasal and nebulised routes. Nebulised dexmedetomidine 1µg/kg effectively blunts increase in heart rate (HR) but not systolic blood pressure (SBP). Dexmedetomidine nebulisation with 2µg/kg dose may help in blunting both tachycardia and hypertensive response.A prospective, randomized, study will be conducted on 150 ASA I and II patients undergoing surgery under general anaesthesia with endotracheal tube (ETT) insertion, who will be divided into 3 groups of 50 patients each. In groups 0, I and II, patients will be nebulised for 10 minutes with 5 ml of 0.9% NaCl solution containing 0, 1 and 2 µg/kg  dexmedetomidine respectively, 10 minutes before induction. Heart rate, Systolic, diastolic and mean arterial pressure (MAP) will be monitored and recorded at regular intervals and the data so collected will be analysed statistically.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-09-21
• Study Start: 2021-09-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

•Age more than 18 years •ASA I & II patients undergoing surgery under general anaesthesia •Patient with Mallampati class 1 or 2.

Exclusion Criteria

•Pregnant females •Patient with unstable haemodynamics •Predicted airway difficulty •ASA III & IV patients •Known allergy to dexmedetomidine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•To find most effective dose of nebulised dexmedetomidine with minimal side effect in blunting haemodynamic response to laryngoscopy and intubation by comparing HR, SBP, DBP and MAP at pre-induction, pre-intubation, after-intubation and upto 10 minutes post intubation.	BASELINE, after 5 mins i.e during nebulisation, after 10 mins i.e post nebulusiation, Pre-induction, Pre-intubation, Post intubation and then after every one min till BP and HR comes normal.

Secondary Outcome Measures

Name	Time	Method
•To compare effect of 1 & 2 μg/kg nebulised dexmedetomidine on reduction of induction dose of propofol.	•To compare incidence and magnitude of complication associated with use of 1 & 2 μg/kg nebulised dexmedetomidine.

Trial Locations

Locations (1)

Dayanand Medical College and Hospital, Ludhiana.; 🇮🇳 Ludhiana, PUNJAB, India

Dayanand Medical College and Hospital, Ludhiana.

🇮🇳Ludhiana, PUNJAB, India

Dr Suneet Kathuria

Principal investigator

9814007622

suneetkathuria@hotmail.com