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临床试验/CTRI/2017/10/010134
CTRI/2017/10/010134已完成不适用

Monitoring of depth of Anaesthesia using entropy monitor during Cardiopulmonary bypass- a prospective study.

Pragya Sachan1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年2月24日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
monitor the depth of

研究概览

简要总结

The primary purpose of study is to monitor the depth of  Anaesthesia using Entropy monitor during Cardiopulmonary bypass on the basis of Numerical Indices provided by Entropy Monitor (Response Entropy {RE} and

State Entropy {SE}, Burst Suppression Ratio {BSR}  and using Modified Version of Brice Questionnaire after 48 hrs of Surgery about any memories or recall of Intraoperative awareness. Awareness under anaesthesia is terrifying both to the patients and anesthesiologist,its incidence increases all the more during cardiac surgery. Also, during Cardiac Surgery, hemodynamic signs are less reliable guides to anaesthetic depth, as most patients are heavily treated with beta-blocking drugs and antihypertensive medication. Determining anaesthetic depth during Cardio pulmonary bypass (CPB) with variable degree of hypothermia and increased volume of distribution presents an even more complex situation.

In our study,after skin incision mean RE and SE were foundto decrease significantly till peak hypothermia. After start ofrewarming, mean RE and SE were found to increase significantlytill skin closure. We did not find any awareness in all100 studied subjects, leading to the conclusion that anesthesiatechnique used for CPB is optimal.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patients aged 18-60 years and consenting for monitoring were included in study.

排除标准

  • Patients unwilling and with history of epilepsy,head injury,thromboembolic episodes related or unrelated to cardiac disease were excluded from study.

结局指标

主要结局

monitor the depth of

时间窗: After 18 months of study.

Anaesthesia using Entropy monitor during

时间窗: After 18 months of study.

Cardiopulmonary bypass on the basis of Numerical Indices provided by Entropy Monitor (Response Entropy {RE} and State Entropy {SE}, Burst Suppression Ratio{BSR}

时间窗: After 18 months of study.

次要结局

  • Modified Version of Brice Questionnaire used after 48 hrs of Surgery about any(memories or recall of Intra operative awareness.)

研究者

发起方
Pragya Sachan
申办方类型
Other [Principal investigator]

研究点 (1)

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