Recovery From Propofol Anaesthesia Guided by Frontal EEG Wave Analysis Compared to Bispectral Index Monitoring Alone in Laparoscopic Surgery: A Multicentre Double-blind Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 试验地点
- 4
- 主要终点
- Quality of recovery (QoR): QoR-15 scale
研究概览
简要总结
Processed electroencephalogram (EEG) monitors are routinely used in addition to clinical parameters to assess the depth of anaesthesia during general anaesthesia.
详细描述
Processed electroencephalogram (EEG) monitors are routinely used in addition to clinical parameters to assess the depth of anaesthesia during general anaesthesia. In addition to the bispectral (BIS) index displayed as an index, the raw frontal EEG can be displayed as a curve on these monitors. After a short training, anaesthetists might be more accurate and faster in assessing depth of anaesthesia by recognizing the pattern of the EEG curve than by using the BIS index. This may further enhance the positive effects that could be demonstrated for the use of BIS monitors.
Therefore, the aim of the investigator's study is to investigate the clinical relevance of interpreting the raw frontal EEG in addition to only using the BIS index for titrating intravenous anaesthetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Adult patients undergoing in-hospital laparoscopic abdominal surgery with general anaesthesia using Propofol based on the Schnider model (target controlled infusion)42, 43
- •Minimal duration of surgery of 60 minutes
- •Written informed consent
排除标准
- •Same-day surgery
- •Language barrier
- •Patients under 18 years of age
- •Pregnancy (using a beta-human chorionic gonadotropin (HCG) measurement in a blood sample of women in childbearing age)
- •Allergy to Propofol
- •Administration of hypnotics other than Propofol, such as ketamine or midazolam preoperatively or intraoperatively
- •Known brain pathology, such as seizure disorders, dementia, cerebrovascular disease or brain death
结局指标
主要结局
Quality of recovery (QoR): QoR-15 scale
时间窗: 24 hours after surgery
QoR-15 scale (scale from 0 to 150; 0 means best, 150 worst recovery)
次要结局
- Quality of recovery (QoR): QoR-15 scale(48 hours after surgery)
- Aldrete score(Once at discharge from postanaesthesia care unit (PACU), approximately on day 2 of admission to hospital)
- Time spent in postanaesthesia care unit (PACU)(At arrival to and at discharge from postanaesthesia care unit (an average of 120 minutes))
- Risk of awareness(daily from admission up to hospital discharge, an average of approximately 14 days)
- Propofol consumption(during anaesthesia)
- Time to extubation(At time of skin closure and at time of extubation (an average of 90 minutes))
- Incidence of Postoperative Nausea and Vomiting (PONV)(daily from admission up to hospital discharge, an average of approximately 14 days)