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临床试验/NCT00162591
NCT00162591Unknown不适用

Bispectral Index as an Analgesia Monitoring in Severely Ill Patient: Effect of Remifentanyl

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2004年10月最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
BIS variation during bronchoalveolar lavage

研究概览

简要总结

The aim of this protocol is to study the prophylactic effect of remifentanil on bispectral index variation during a nociceptive stimuli.

详细描述

Pain is difficult to estimate in ICU because most of the patients are sedated. Bispectral index could be helpful in detecting this pain in ICU patients. Remifentanil is a morphinomimetic product with short half life that could be interesting for short nociceptive stimuli, as bronchoalveolar lavage.

The purpose of this study is to evaluate the impact of remifentanil infusion on bispectral index (BIS) variations during bronchoalveolar lavage.

It is a prospective, double blind study, versus placebo on 40 sedated and critically ill patients.

The hypothesis is that BIS can study analgesia in sedated patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double

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

  • Sedated patient with mechanical ventilation with suspected nosocomial pneumonia

排除标准

  • Pace maker
  • Neurologic illness
  • Hemodynamic instability
  • Hypothermia

结局指标

主要结局

BIS variation during bronchoalveolar lavage

次要结局

  • Systolic blood pressure, diastolic blood pressure, heart rate viation

研究者

申办方类型
Other

研究点 (2)

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