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临床试验/CTRI/2024/12/078128
CTRI/2024/12/078128招募中不适用

Evaluation of induction characteristics of Propofol and Etomidate for I-gel insertion using Bispectral Index (BIS) guided induction of General Anaesthesia. A prospective randomised double-blinded clinical trial.

All India Institute Of Medical Sciences Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月27日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Time taken to achieve BIS50

研究概览

简要总结

•After taking informed consent ,patients will be randomly assigned to one of the 2 group according to computer generated random number table.

Group P – this group of participants will receive Infusion Propofol till BIS 50 is achieved

Group E – this group of participants will receive Infusion Etomidate till BIS 50 is achieved.

•The total time taken to reach BIS 50 will be calculated.

•Dose required to achieve BIS 50 will be noted.

•Ease of I-gel insertion by degree of jaw relaxation and overall I-gel insertion conditions will be assessed.

•Haemodynamic changes and other adverse effects will be noted.

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

  • ASA 1 and 2 2)BMI less than 35 3)Posted for elective surgery under general anaesthesia.

排除标准

  • Posted for emergency surgery 2)Allergic to propofol and etomidate 3)Anticipated difficult airway 4)Adrenal insufficiency or seizure patients 5)Pregnant females.

结局指标

主要结局

Time taken to achieve BIS50

时间窗: Time taken to achieve BIS50 at baseline ,before start of induction agent infusion,before i gel insertion,1 minute after i gel insertion,3 minutes after i gel insertion,5 minutes after i gel insertion

次要结局

  • Dose required to achieve BIS 50(Igel ease of insertion characterstics)

研究者

发起方
All India Institute Of Medical Sciences Department of Anaesthesiology
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sai Mani Kanta Bandla

All India Institute Of Medical Sciences, Rajkot

研究点 (1)

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