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临床试验/NCT00391963
NCT00391963已完成不适用

Comparison of the Bispectral Index and the Entropy of the Electroencephalogram During Total Intravenous Anesthesia

Hopital Foch2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2006年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Hopital Foch
入组人数
84
试验地点
2

研究概览

简要总结

To compare Bispectral index and entropy during maintenance of anesthesia

详细描述

Several monitors are currently proposed to evaluate the depth of hypnosis. Among them, Bispectral Index (BIS) is a well known and widely used parameter derived from the patient's electroencephalograph (EEG). Spectral entropy relies on the extent of disorder in both EEG and electromyography (EMG) signals and returns 2 values: State Entropy (SE) and Response Entropy. SE is computed over the frequency range of 0.8-32 Hz and reflects the level of hypnosis while Response Entropy is computed over the frequency range of 0.8-47 Hz and reflects also EMG activity. BIS and SE are dimensionless numbers scaled from 100 to 0 for BIS and from 91 to 0 for SE.

The BIS and Entropy manufacturers claim that adequate level of anesthesia is defined by a BIS or SE value between 40 and 60. But some observations have shown that the monitors provided different information. These observations led us to carry out this prospective observational study designed to study the comparability between BIS and SE during the maintenance period of propofol-sufentanil anesthesia.

研究设计

研究类型
Observational
时间视角
Prospective

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

  • age > 18 years,
  • American Society of Anesthesiologists physical status 1-3,
  • surgery under general anesthesia using propofol, sufentanil, and a relaxant agent,
  • surgery lasting more than one hour,
  • tracheal extubation planned at end of surgery

排除标准

  • pregnant women,
  • allergy to propofol,
  • neurological or muscular disorder,
  • treatment with opioids or any psychoactive medication,
  • cardiac surgery,
  • thyroid disorder,
  • emergency surgery,
  • prone or lateral decubitus position (difficulty to have a correct probe position)

研究者

发起方
Hopital Foch
申办方类型
Other

研究点 (2)

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