跳至主要内容
临床试验/NCT00477347
NCT00477347终止4 期

Comparison of Manual Propofol and Remifentanil Administration and Dual Closed-loop, Using Bispectral Index as the Control Variable, During Liver Transplantation

Hopital Foch4 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2007年5月最近更新:
适应症

试验速览

阶段
4 期
状态
终止
发起方
Hopital Foch
入组人数
5
试验地点
4
主要终点
consumption of propofol during anesthesia maintenance

研究概览

简要总结

To compare closed-loop anesthesia to manual administration of propofol and remifentanil during liver transplantation

详细描述

The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. We hypothesized that BIS can also indicate the adequacy of analgesia. Therefore we built a combined closed-loop anesthesia system using BIS as control variable and two proportional-differential control algorithms, a propofol and a remifentanil target-controlled infusion system. The effectiveness of such a closed-loop anesthesia system has been demonstrated in a prospective, randomized study.

Elimination of anesthetic agents, propofol in particular, is strongly reduced during liver transplantation. Closed-loop anesthesia could provide adequacy for requirements in respect to the various phases of transplantation. 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 range recommended by the manufacturer during anesthesia. We expect the combined closed-loop anesthesia system group to do better: i.e. diminished consumption of propofol (primary outcome measure).

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
Single (Participant)

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

  • liver transplantation

排除标准

  • pregnant women
  • allergy to propofol or remifentanil,
  • neurological or muscular disorder,
  • liver encephalopathy,
  • patients taking psychotropic agents

结局指标

主要结局

consumption of propofol during anesthesia maintenance

时间窗: during anesthesia maintenance

次要结局

  • - consumption of remifentanil - target modifications - hemodynamic events - volume loading and transfusion - extubation time, explicit memorization - time passed at BIS between 40 and 60 - MDAPE, wobble - global score - dysfunction of each system.(during anesthesia maintenance)

研究者

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

研究点 (4)

Loading locations...

相似试验

Closed-loop Anesthesia, Using Bispectral Index as... | 临床试验