跳至主要内容
临床试验/CTRI/2024/03/063833
CTRI/2024/03/063833尚未招募4 期

“Comparison of electroencephalogram entropy versus loss of verbal response to determine the dosage of propofol for induction of general anaesthesia in adult patients undergoing elective surgeries ” A randomised controlled study.

KUSHAL YALABURGI1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年3月20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
50
试验地点
1
主要终点
1. The dose of propofol required for induction of general anesthesia, as determined by EEG entropy and loss of verbal response.

研究概览

简要总结

Pre anesthetic evaluation and Selection of the patients.

Baseline  measurement  of  haemodynamic parameters and induction of anaesthesia .

Assessment of dosage of propofol required for induction of general anesthesia during entropy/loss of verbal response.

Assessment of patients haemodynamic parameters  and values of entropy intra operatively during the timings mentioned above.

Data Analysis

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant 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

  • Age 18 to 60 YEARS
  • Patient willing to give informed consent and procedure as per the declaration of Helsinki guidelines
  • American society of Anesthesiologist Physical Status : ASA 1,2 in patients undergoing elective surgeries under general anaesthesia.

排除标准

  • Patients with severe cardiac disease, liver diseases and renal dysfunction.
  • Patients not willing to give informed consent.
  • Emergency procedures.
  • Patients with hearing disorders.

结局指标

主要结局

1. The dose of propofol required for induction of general anesthesia, as determined by EEG entropy and loss of verbal response.

时间窗: during induction of anaesthesia

次要结局

  • 2. Incidence of adverse events, such as hypotension, bradycardia during induction of anesthesia.(one, five & 10 mins after induction of anaesthesia)

研究者

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

KUSHAL YALABURGI

Bangalore Medical College and research institute

研究点 (1)

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