跳至主要内容
临床试验/NCT00393003
NCT00393003已完成4 期

Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index: Comparison Between Manual Perfusion and Automated Perfusion

Hopital Foch2 个研究点 分布在 1 个国家目标入组 32 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
32
试验地点
2
主要终点
Global score (calculated parameter which depicts the performance of the system)

研究概览

简要总结

This prospective randomized study evaluates the effectiveness of a closed-loop anesthesia system during the postoperative period.

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, two proportional-integral-differential control algorithms, a propofol and a remifentanil target-controlled infusion systems as the control actuators. Preliminary results show that this system can be used during surgery. We propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system during the postoperative period. 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 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
  • •Abdominal aorta surgery

排除标准

  • •Pregnant women
  • •Neurological or muscular disorder

结局指标

主要结局

Global score (calculated parameter which depicts the performance of the system)

次要结局

  • Consumption of propofol and remifentanil, modifications of target of propofol and remifentanil, dysfunction of each system, hemodynamic abnormalities, sedation scale, volume loading, extubation time, explicit memorisation.

研究者

发起方
Hopital Foch
申办方类型
Other

研究点 (2)

Loading locations...

相似试验