Monitoring of Anaesthetic Depth at Different Locations in the Cerebral Cortex Using Bispectral Bilateral System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Bilateral BIS values from frontal and parietal areas.
研究概览
简要总结
This is a prospective, observational study, aimed to establish changes of bispectral bilateral system in both cerebral hemispheres during a total intravenous anaesthesia during breast surgery in the woman. By placing two Bispectral bilateral sensors (BIS), one on both frontal lobes, and another on both parietal lobes, we wanted to evaluate differences between frontal and parietal areas, when the patient is awake and during the anaesthetic procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Aged more than 18 years old.
- •Scheduled for general anaesthesia.
- •Agree to participate(signed inform consent).
排除标准
- •Neurological disease.
- •Cognitive impairment.
- •Egg allergy.
- •Severe disease or condition that could potentially interfere with interpretation of tests.
结局指标
主要结局
Bilateral BIS values from frontal and parietal areas.
时间窗: Bilateral BIS values will be taken at baseline, anaesthetic induction, endotracheal intubation, skin incision, mantenance of anaesthesia and in emergence from anaesthesia ( 3 hours as a maximum from baseline to emergence).
次要结局
- EEG changes at LOC (loss of consciousness) and ROC (recovery of consciousness).(Changes will be evaluated at induction and emergence.)
研究者
Juan Luis Fernández Candil
MD
Parc de Salut Mar