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临床试验/NCT01868178
NCT01868178已完成不适用

Relationship Between Bispectral Index (BIS) and Spectral Entropy (SpEn) During Desflurane Anaesthesia

Catholic University of the Sacred Heart2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
BIS index

研究概览

简要总结

The aim of this study was to estimate the relationship between BIS and Spectral Entropy values and any explicit or implicit memory or dreams recall during desflurane anaesthesia.

详细描述

During the last decade, an increasing number of monitor systems were developed designed to assess the depth of anesthesia.

Awareness is a rare occurrence of explicit recalls during anaesthesia with an incidence of 0,18% and the use of cerebral monitoring prevents about 50% of these events.

Different stages of awareness should be defined and implicit memorization is subconscious awareness without explicit recall and possible implicit recall with an incidence greater than awareness.

To assess implicit recalls, a large number of test can be used, for example the "word stem completation test" and the "free recall association test". These result easy to use and reliable in detect implicit memory.

Bispectral Index (BIS) and Spectral Entropy (SpEn) has been proposed, in recent years, as electroencephalographic monitors of anaesthesia depth.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • American society of anesthesiologist physical status I-II
  • Italian native speakers

排除标准

  • Psychiatric or neurologic diseases
  • Acoustic impairment
  • Obesity (Body Mass Index > 30)
  • Substance dependence.

结局指标

主要结局

BIS index

时间窗: change from baseline at 15 min

次要结局

  • entropy values(24 h after emergency from anaesthesia)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Germano De Cosmo

PhD

Catholic University of the Sacred Heart

研究点 (2)

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