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临床试验/CTRI/2025/06/089416
CTRI/2025/06/089416尚未招募4 期

Comparison of tracheal extubation time using bispectral index versus end-tidal anaesthetic gas concentration monitoring in adults undergoing laparoscopic cholecystectomy under sevoflurane-based general anaesthesia

Dr Lalhmangaihzuali1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月7日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Tracheal extubation time (in minutes) in BIS and ETAG group

研究概览

简要总结

This study is a prospective, randomized comparative study aimed at evaluating the difference in tracheal extubation time between bispectral index monitoring and end-tidal anaesthetic gas concentration monitoring in adult patients undergoing laparoscopic cholecystectomy under sevoflurane-based general anaesthesia. Sixty patients aged 18 to 60 years, classified as ASA grade 1 or 2, will be randomly assigned to either BIS or ETAG groups. Anaesthetic depth will be maintained using BIS values 40 to 60 or ETAG MAC levels 0.7 to 1.3. Extubation time will be recorded as the primary outcome. Secondary outcomes include comparisons of hemodynamic parameters, recovery time and intraoperative awareness. This study seeks to determine which monitoring method facilitates quicker and safer emergence from anaesthesia.

研究设计

研究类型
Interventional
分配方式
Other
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 grade 1 or 2 Surgery duration of 30 to 60 minutes.

排除标准

  • BMI>30kg/m2 Psychiatric disorders Epilepsy On chronic hypnotics/sedatives Renal disease Active neurological disease Neuromuscular disease.

结局指标

主要结局

Tracheal extubation time (in minutes) in BIS and ETAG group

时间窗: 60 minutes

次要结局

  • Haemodynamic parameters in BIS & ETAG group(At 0 & every 5 minutes till extubation of tracheal tube)
  • Recovery time in BIS & ETAG group(At 0 minute & every 5 minutes in the Post Anaesthesia Care Unit)
  • Intraoperative awareness in BIS & ETAG group(Within 12 to 24 hours after surgery)

研究者

发起方
Dr Lalhmangaihzuali
申办方类型
Other [self]

研究点 (1)

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