A clinical trial to evaluate the effect preoperative intranasal Dexmedetomidine to decrease hypertensive response of laryngoscopy and endotracheal intubation in elective lumber spine surgery.

Phase 2/3

Completed

• Conditions: 1. Preoperative anxiety and preoperative sedation.2. Hemodynamic response to laryngoscopic surge and endotracheal intubation

• Registration Number: CTRI/2016/10/007384
• Lead Sponsor: Bangur Institute of Neurosciences Kolkata

Brief Summary

This study is a randomized, double blinded placebo controlled trial comparing the safety and efficacy of Intranasal Dexmedetomidine (1 mcg/kg body weight) with Oral Daizepam (0.2 mg/kg body weight) versus intranasal placebo with Oral Diazepam ( 0.2 mg/kg body weight) only, in 70 adult patients undergoing elective lumbar spine surgery in 1 centre in India.

The primary outcome measures are:

1. Preoperative reduction in anxiety and preoperative sedation, measured upto 45 minutes prior to induction of anaesthesia.

2. Hemodynamic response measured by Heart Rate and Blood pressure variation to laryngoscopy and endotracheal intubation measured upto 10 mins after intubation.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-03
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Patients with ASA physical status I, patients having Mallampati I and II, patients with body mass index (BMI) < 30 kg/m2.

Exclusion Criteria

• Patients refusal to participate in the study.Known allergy or hypersensitive reaction to dexmedetomidine or diazepam.
• Patients suffering from significant cardiac disease e.g IHD, cardiomyopathy, valvular disorder, hypertension, arrhythmia, etc.
• Patients suffering from significant respiratory disease e.g COPD, bronchial asthma, interstitial lung diseases, pneumonia etc.
• Patients having metabolic, endocrinal, musculoskeletal, neurologic disorder or having major congenital anomalies.
• History of drug abuse and/or psychiatric disorder.
• Pregnant women; no reliable contraceptive measures in postmenopausal women.
• Patients taking antihypertensive drugs such as methyldopa, clonidine and other α2 receptor agonists.
• Patients having morbid obesity, obstructive sleep apnoea, suspected difficult airway.
• Patients having liver and kidney dysfunction.
• Patients having long-term use of sedatives and analgesics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sedation and preoperative reduction in anxiety.	Sedation and anxiety upto 45 mins before induction of General anaesthesia, hemodynamic variation from preinduction upto 10 mins after endotracheal intubation.
Heart Rate (variation of 10 beats/min) and Blood pressure variation to laryngoscopy and endotracheal intubation.	Sedation and anxiety upto 45 mins before induction of General anaesthesia, hemodynamic variation from preinduction upto 10 mins after endotracheal intubation.

Secondary Outcome Measures

Name	Time	Method
Any side effects including bradycardia and hypotension.	during the whole study period.

Trial Locations

Locations (1)

Bangur Institute of Neurosciences, Neuroanesthesia department,Kolkata.; 🇮🇳 Parganas, WEST BENGAL, India

Bangur Institute of Neurosciences, Neuroanesthesia department,Kolkata.

🇮🇳Parganas, WEST BENGAL, India

DRSAIKAT NIYOGIASSOCIATE PROFESSOR

Principal investigator

9831732443

saikatneuro1972@gmail.com