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."
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
- 否
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
研究点 (1)
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