跳至主要内容
临床试验/NCT00571181
NCT00571181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 During Rigid Bronchoscopy

Hopital Foch2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2007年12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
66
试验地点
2
主要终点
Percentage of time with BIS in the desired range

研究概览

简要总结

The purpose of this study is to compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during rigid bronchoscopy.

详细描述

The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. We have 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. A recent study has shown that such system is able to provide clinically adequate anesthesia. The aim of the present study is to assess the system during rigid bronchoscopy. 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

  • patients undergoing rigid bronchoscopy under general anesthesia

排除标准

  • pregnant women
  • allergy to propofol or remifentanil
  • neurological disorder
  • psychotrop treatment

结局指标

主要结局

Percentage of time with BIS in the desired range

时间窗: During the procedure

次要结局

  • extubation time(during the procedure)
  • consumption of propofol and remifentanil(during the procedure)
  • explicit memorisation(postoperative day 2)

研究者

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

研究点 (2)

Loading locations...

相似试验

Automated Anesthesia During Bronchoscopy | 临床试验