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临床试验/NCT00408941
NCT00408941Unknown4 期

EEG and Auditory Evoked Potentials During Local Anesthesia

Technical University of Munich2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2006年12月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
发起方
入组人数
15
试验地点
2
主要终点
differences of AEP during sedation with and without local anaesthesia

研究概览

简要总结

The aim of the present study was to investigate the sensitivity of AEP (auditory evoked potentials) to muscular artefacts using sedation and local anesthesia.

详细描述

Spontaneous or evoked electrical brain activity is increasingly used to monitor general anesthesia. During alertness, surgery and anesthesia the quality of AEP recordings may be reduced by artefacts. This poses the question to what extent AEP are sensitive for muscular artefacts. High frequency artefacts can have its seeds in muscles and in technical instruments in the operating room. Therefore, the study will take place under the terms of laboratory.

The present study was designed to measure the influence of muscular artefacts on AEP under propofol sedation with or without local anesthesia in the area of the electrodes.

If artefacts influence AEP, which are used to measure anesthesia, it is particularly interesting with regard to clinical application. AEP as a measure of "anesthetic depth" may not only reflect brain, but also muscular and high frequency activity. Therefore, while using muscle relaxants, the AEP of an awake patient may indicate deep anesthesia, because muscle signals are absent.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) physical status 1-2

排除标准

  • drugs that effect the central nervous system
  • neurological or psychiatric deceases
  • contraindications against use of propofol or local anesthesia

结局指标

主要结局

differences of AEP during sedation with and without local anaesthesia

次要结局

  • fraction of high frequency artefacts
  • time to LOC
  • differences AEP awake with and without local anaesthesia

研究者

发起方
Technical University of Munich
申办方类型
Other

研究点 (2)

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