临床试验/CTRI/2024/09/073684

CTRI/2024/09/073684已完成4 期

Comparison between IV Dexmedetomidine with Ketamine and IV Dexmedetomidine with Fentanyl on Intubating Conditions During Awake Fibreoptic Intubation: A Prospective Randomised Double Blind study

Maharana Bhupal Government Hospital1 个研究点分布在 1 个国家目标入组 64 人开始时间: 2024年10月1日最近更新: 2024年9月6日

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 64
试验地点: 1
主要终点: Cough score(severity of cough) during awake fibreoptic intubation

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

We would like to compare intravenous dexmedetomidine with intravenous Ketamine and intravenous dexmedetomidine with intravenous Fentanyl on intubating conditions during awake fiberoptic intubation in term of cough score, intubating condition, Ramsay sedation score , hemodynamic parameters, side effects/complications if any. Kindly grant CTRI registration for our study as IV Dexmedetomidine with ketamine and IV Dexmedetomidine with Fentanyl are FDA approved drugs.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•Patient with ASA Grade I and II Patient undergoing elective surgery under general anaesthesia Patient with Mallampati Class I and II.

排除标准

•Patient refusal Psychiatric patients Emergency surgery Patients with severe bradycardia/heart block Pregnant and lactating mother Patients having known allergy to any drug used in the study Patients contraindicated to nasal intubation such as grossly distorted airway anatomy, URTI and bleeding disorders Patients on long term opioids or sedative medications.

结局指标

主要结局

Cough score(severity of cough) during awake fibreoptic intubation

时间窗: Up to 2 Min after awake fibreoptic intubation

次要结局

Intubating conditions(Vocal cord position)

研究者

发起方

Maharana Bhupal Government Hospital

申办方类型

Government medical college

责任方

Principal Investigator

主要研究者

Dr Sandeep Sharma

R.N.T Medical College

研究点 (1)

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