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临床试验/NCT00391885
NCT00391885已完成4 期

Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy of the Electroencephalogram: Comparison Between Manual Perfusion and Automated Perfusion

Hopital Foch2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年9月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
Hopital Foch
入组人数
60
试验地点
2
主要终点
Global score (calculated parameter which depicts the performance of the system, i.e. its capacity to maintain BIS in the desired range)

研究概览

简要总结

This study compares the manual administration of propofol and remifentanil and their delivery using a combined closed-loop anesthesia system, entropy of the EEG being the controller.

详细描述

Several monitors are currently proposed to evaluate the depth of hypnosis. Among them, Bispectral Index (BIS) is a well known and widely used parameter derived from the patient's electroencephalograph (EEG). A closed-loop anesthesia system can be built using BIS as the control variable, a proportional-integral-differential control algorithm, a propofol and a remifentanil target-controlled infusion systems as the control actuators Preliminary results show that this system can be used during surgery.

Spectral entropy relies on the extent of disorder in both EEG and electromyography (EMG) signals and returns 2 values: State Entropy (SE) and Response Entropy. SE is computed over the frequency range of 0.8-32 Hz and reflects the level of hypnosis while Response Entropy is computed over the frequency range of 0.8-47 Hz and reflects also EMG activity. BIS and SE are dimensionless numbers scaled from 100 to 0 for BIS and from 91 to 0 for SE. We hypothesized that SE can be used as the control variable. In preparation for a large multi-center control trial, we propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system. Two groups of patients are compared: one in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion systems, and one in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system. In both groups, the goal is to maintain SE between 40 and 60, the recommended range during anesthesia by the manufacturer. We expect the combined closed-loop anesthesia system group to do similar or better.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •American Society of Anesthesiologists physical status 1-3,
  • •surgery under general anesthesia using relaxant agent,
  • •surgery lasting more than one hour

排除标准

  • •pregnant women,
  • •indication for rapid sequence induction,
  • •anticipation of difficult intubation,
  • •allergy to propofol or remifentanil,
  • •neurological or muscular disorder,
  • •combination of general anesthesia and of regional anesthesia,
  • •emergency surgery

结局指标

主要结局

Global score (calculated parameter which depicts the performance of the system, i.e. its capacity to maintain BIS in the desired range)

次要结局

  • consumption of propofol and remifentanil during the induction and the maintenance of the anaesthesia
  • number of modifications of target of propofol and remifentanil
  • number of episodes of hemodynamic anomalies having required a treatment
  • intraoperative volume loading and transfusion
  • extubation time, explicit memorisation
  • dysfunctions of each system

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (2)

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