跳至主要内容
临床试验/NCT01060631
NCT01060631已完成不适用

"Assessment of the Influence of Intracranial Space Occupying Lesions on the Reliability Off Monitoring of the Bispectral Index for Detection of Return of Consciousness."

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年11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
40
试验地点
1
主要终点
Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor.

研究概览

简要总结

The purpose of this study is to assess whether BIS values at return of consciousness are different in patients with or without brain tumors.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Patients undergoing elective craniotomy for removal of frontal or frontotemporal brain tumors.
  • Control group: Neurosurgical patients without intracranial pathology.

排除标准

  • Patient refusal
  • Significantly increased intracranial pressure
  • Uncontrolled arterial hypertension
  • Significant coronary artery disease
  • Anticipated difficult airway
  • Decreased level of consciousness
  • Existing motor weakness dominant arm/hand
  • Impaired hearing
  • Nausea, vomiting

结局指标

主要结局

Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor.

时间窗: one year

次要结局

  • Difference between left- and rightsided BIS values in patients with supratentorial brain tumor during course and Comparison between predicted and measured propofol plasma concentrations during course of the study(one year)

研究者

申办方类型
Other

研究点 (1)

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