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临床试验/NCT00599066
NCT00599066已完成不适用

Same-patient Reproducibility of Intraoperative M-Entropy Measurements

University of Oklahoma1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2007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
24
试验地点
1
主要终点
The investigators hypothesize that simultaneous M-Entropy measurements from the left and right side of the forehead of a person do not differ during general anesthesia.

研究概览

简要总结

The purpose of this study is to learn more about an Entropy monitor that the anesthesiologist will be using.

详细描述

Depth of anesthesia monitors are increasingly used in clinical anesthesia practice. Bispectral Index (BIS) and M-Entropy are examples to these devices, both of which are available at our institution. Both BIS and M-Entropy use a unilateral, single channel of EEG to derive a number indicating the anesthetic depth. These devices have similar disposable skin probes that can be applied on either side of the forehead. Since the depth of anesthesia for an individual is the same over the whole brain cortex at a given point in time, BIS numbers obtained over the left and right side of the forehead should agree. The same should be true for M-Entropy as well.

A recent study, however, showed that two separate BIS probes, applied over the left and right forehead of the same patient at the same time, can give significantly different numbers. This has not been studied for M-Entropy. BIS and M-Entropy use different mathematical algorithms that process the raw EEG signal to compute a numeric value. Therefore, it is possible that M-Entropy may show different results in a similar study setup.

The aim is to investigate the same-patient reproducibility of M-Entropy by monitoring and recording Entropy variables over both the left and the right side of the forehead of patients under general anesthesia.

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
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled to have surgery under general anesthesia, with a minimum of 60 minutes expected duration.

排除标准

  • Non-English speaker
  • Patients younger than 18 years of age

结局指标

主要结局

The investigators hypothesize that simultaneous M-Entropy measurements from the left and right side of the forehead of a person do not differ during general anesthesia.

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Intraoperative M-Entropy Measurements | 临床试验