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临床试验/CTRI/2025/08/093142
CTRI/2025/08/093142尚未招募不适用

Comparison of Bispectral Index (BIS)-guided vs Clinically guided propofol induction in Adult Patients undergoing Elective Surgery under General Anaesthesia: A Prospective Randomised Clinical Trial

Prameela1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To evaluate and compare the effectiveness of BIS guided vs clinical guided anaesthesia induction by measuring propofol requirement

研究概览

简要总结

The aim of my study is to evaluate the effectiveness and safety of clinical vs BIS guided anesthesia induction using propofol infusion The study aims is to give the correct dose of propofol which improves the hemodynamic profile of the patients , increase the post op recovery .

•In OT, Baseline parameters NIBP, HR, ECG, SpO2 noted    Preoxygenation by 100 percent O2 followed by IV Fentanyl 2 mcg/kg

•In Group B, infusion at 30 mg/kg/hr till BIS 50 ±  2

•In Group C, Propofol infusion at 30 mg/kg/hr till loss of verbal reflex

Atracurium 0.5 mg/kg , Endo Tracheal Intubation. Hemodynamic parameters and speed of anaesthesia induction to be recorded

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patient ready to give informed written consent Men and women aged 18 years and older ASA physical status class I to III Patient coming for elective surgery under general anaesthesia.

排除标准

  • Pregnant female Lactating mother Baseline BP and/or HR fall greater than 20% on induction Emergency surgeries.

结局指标

主要结局

To evaluate and compare the effectiveness of BIS guided vs clinical guided anaesthesia induction by measuring propofol requirement

时间窗: Induction time

次要结局

  • To evaluate the safety profile of BIS guided vs clinical guided anaesthesia induction by measuring hemodynamic parameters(Induction time)

研究者

发起方
Prameela
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

PRAMEELA

AIIMS RAJKOT

研究点 (1)

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