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临床试验/NCT01720615
NCT01720615已完成4 期

Detection of Consciousness by EEG and Auditory Evoked Potentials

Technical University of Munich1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2001年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Changes in EEG- and AEP-parameters during loss- and return of consciousness

研究概览

简要总结

The objective of the present investigation is to analyze EEG and auditory evoked potentials at the transition from consciousness to unconsciousness and vice versa. A set of electroencephalographic and auditory evoked potential parameters should be identified that allows separation of consciousness from unconsciousness (reflected by responsiveness/unresponsiveness to command). The study is based on data of 80 patients undergoing general anesthesia with remifentanil and either sevoflurane or propofol.

详细描述

During the past years, monitoring of anesthetic effects on the main target of anesthesia, the brain, has gained increasing attention. Monitoring of the spontaneous electroencephalogram (EEG) and of auditory evoked potentials (AEP) has been suggested. Even if EEG and AEP reflect effects of anesthetic drugs, a visual interpretation is not expedient. As a consequence, several processing methods have been suggested that reduce the electroencephalogram to a numerical value. In the current study, a set of EEG- and AEP parameters based on different analysis methods is tested with respect to the parameters ability in separating consciousness (reflected by responsiveness to command) from unconsciousness at the transition between these stages. Therefore data of 80 unpremedicated patients undergoing general anesthesia with remifentanil and either sevoflurane or propofol is used. The study period is from induction of anesthesia until patients follow command after surgery and includes a reduction of the hypnotic agent after tracheal intubation until patients follow command. The isolated forearm technique is applied before muscle relaxants are given to maintain the ability to squeeze hand to command.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • Patients with contraindications to the study drugs
  • psychiatric or neurologic disease
  • drug abuse or medication known to affect the central nervous system
  • pregnancy
  • indication for rapid sequence induction

研究组 & 干预措施

Propofol or Sevoflurane

No Intervention

General anesthesia

干预措施: Propofol / Remifentanil (Drug)

Propofol or Sevoflurane

No Intervention

General anesthesia

干预措施: Sevoflurane / Remifentanil (Drug)

结局指标

主要结局

Changes in EEG- and AEP-parameters during loss- and return of consciousness

时间窗: 1 day

次要结局

  • Impact of muscle activity on EEG- and AEP-parameters(1 day)
  • Influence of anesthetics on EEG- and AEP-parameters(1 day)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gerhard Schneider

Dr. med.

Technical University of Munich

研究点 (1)

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