NCT01483547已完成不适用
Reliability of Bispectral Index for Depth of Anesthesia Monitoring in Neurosurgical Patients
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta1 个研究点 分布在 1 个国家目标入组 405 人开始时间: 2011年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 405
- 试验地点
- 1
- 主要终点
- BIS values at LOC, PI and ROC
研究概览
简要总结
The aim of the study is to assess the reliability of Bispectral Index (BIS Vista , Covidien) in neurosurgical patients . BIS values at Loss of Consciousness (LOC), Post Intubation (PI) and Return of Consciousness (ROC) in neurosurgical patients are compared to those of non-neurosurgical patients, during routine anesthesia procedures.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BIS > 90 at baseline (awake)
- •ASA I or II
排除标准
- •GSC < 15
- •anticipated difficult ventilation and/or intubation
- •BMI > 30
- •surgical site that does not allow BIS monitoring
- •bilateral hearing loss
- •not speaking Italian Language
结局指标
主要结局
BIS values at LOC, PI and ROC
时间窗: 8 months
次要结局
- incidence of intraoperative awareness(0, 1, 3, 30 days after surgery)
- incidence of postoperative delirium(0, 1, 3, 30 days after surgery)
- predicted site effect drugs concentration at LOC, PI and ROC(8 months)
- total amount of anesthetic drugs delivered at the end of surgery(8 months)
- recovery time after surgery(8 months)
研究者
Carla Carozzi, MD
Doctor, Dept. of Neuroanesthesia and Intensive Care
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
研究点 (1)
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