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临床试验/NCT01142635
NCT01142635已完成4 期

The Appearance of Electromyography on the Anaesthesia Monitor.

Tampere University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年4月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
30
试验地点
1
主要终点
The behaviour of biosignal on the anaesthesia monitor

研究概览

简要总结

Intubation may induce electromyographic (EMG) activity, causing depth of anaesthesia monitors to show misleadingly high values. The investigators want to investigate whether this EMG activity can be visually seen on the anaesthesia monitor.

详细描述

Patients are anaesthetized with target controlled infusion of propofol. To facilitate intubation, the patients are randomized to receive rocuronium either 0,6 mg/kg or 1,2 mg/kg. BIS, Entropy and the biosignal collected with the Entropy strip are collected on a computer. The visible biosignal on the anaesthesia monitor is recorded with a video camera. BIS, Entropy, biosignal and video clip of the anaesthesia monitor will be analyzed in detail.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • females giving informed consent
  • age range 18-65 years
  • elective surgery: gynaecological
  • general anaesthesia
  • ASA classification 1 or 2

排除标准

  • pregnancy
  • body mass index > 30
  • disease affecting CNS
  • overuse of alcohol
  • drug abuse
  • unability to understand, read or use Finnish language

结局指标

主要结局

The behaviour of biosignal on the anaesthesia monitor

时间窗: 30 minutes

The visibility of elctromyogram and elctroencephalogram on the anaesthesia monitor

次要结局

  • The behaviour of depth of anaesthesia indexes (BIS, SE, RE) during intubation(30 min)

研究者

申办方类型
Other

研究点 (1)

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