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临床试验/NCT00392158
NCT00392158已完成4 期

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

Hopital Foch12 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2006年2月最近更新:
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
240
试验地点
12
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

To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during anesthesia

详细描述

The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. A closed-loop anesthesia system can be built using BIS as the control variable, a proportional-integral-differential control algorithm, and a propofol target-controlled infusion system as the control actuator. Recent studies have shown that such system is able to provide clinically adequate anesthesia. We hypothesized that BIS can also indicate the adequacy of analgesia and therefore built a combined closed-loop anesthesia system using BIS as the control variable, two proportional-integral-differential control algorithms, a propofol and a remifentanil target-controlled infusion systems as the control actuators. 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 BIS 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

入选标准

  • 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

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

研究者

发起方
Hopital Foch
申办方类型
Other

研究点 (12)

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