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临床试验/NCT00434382
NCT00434382Unknown不适用

Neuronale Mechanismen Der Sensorischen Reizverarbeitung in Der Narkose

Ludwig-Maximilians - University of Munich4 个研究点 分布在 1 个国家目标入组 768 人开始时间: 2002年10月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
768
试验地点
4
主要终点
Intraoperative signs of inadequate anesthesia

研究概览

简要总结

The ability of Mid Latency Auditory Evoked Potentials for a routine monitoring of sensory suppression should be evaluated during a wide spectrum of clinically common forms general anesthesia.

详细描述

Up to now there is no fully functional and precise technique for accurate assessment for monitoring the degree of unconsciousness during general anaesthesia. Previous studies and results obtained during the project regarding the effect of anaesthetics on single neurons and small neuronal networks indicate that it would be most promising to use a method directly correlating to the integrity of the relevant functional systems. As one goal of the project it was formulated to develop and test a new system for recording and analysis of mid latency auditory evoked potentials (MLAEP), suitable to be used in the clinical surrounding of an operation theatre. Step by step an investigational system was developed, that after obtaining legal approvement was functional in a broad spectrum of cases. In a multicenter study the including 4 clinical centres and 426 patients the reliability of the system was proved. Even under the hard conditions of the OR the apparatus was able to record the signals with sufficient reliability and precision. A clear correlation of MLAEP parameters with clinically defined states of consciousness could be identified. Differences in the effect of the used combinations of general anaesthetics and opioids were identified. An algorithm for automatic analysis of the signals was developed, to allow users with limited knowledge of interpretation of MLAEP signals to use them for monitoring anaesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single

入排标准

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

入选标准

  • •Male and female patients
  • •Scheduled for elective urological, gynaecological or general surgery
  • •ASA status I or II
  • •Age 18 to 65

排除标准

  • •ASA status above II
  • •Operative procedures involving the neurocranium, neck or require other neurophysiologic monitoring
  • •Inability to communicate freely in the german language
  • •Major hearing deficit
  • •Regular centrally acting medication including drug abuse within 3 months prior to the investigation
  • •Participant of an other clinical investigation
  • •Lacking or withdrawal of written informed consent

结局指标

主要结局

Intraoperative signs of inadequate anesthesia

Postoperative recall of events

MLAEP parameters

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (4)

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