Effect of Remifentanil on Electroencephalographic BAR Index During Propofol Anaesthesia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Prediction probability for prediction of anaesthetic endpoints
研究概览
简要总结
Current cortical EEG based depth of anaesthesia monitors do not accurately reflect the effect of opioid drugs. We have developed a new theoretically-based method of analysing the EEG. Our hypothesis is that this new method will more accurately predict depth of anaesthesia than the Bispectral Index (BIS) monitor in patients having elective surgery.
详细描述
Patients aged 18-60 years presenting for elective surgery under general anaesthesia will be recruited. They will be randomised to receive remifentanil effect-site target 0, 2 or 4 ng/ml. Then anaesthesia will be induced with propofol. Loss of the eyelash reflex, response to command and response to electrical stimulation will be measured. The raw EEG will be recorded and analysed off-line using our new method and also for BIS values. Anaesthesia will then proceed according to the needs of the patient and the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients, aged 18-60 years, of ASA physical status 1-3, presenting for elective surgery under general anaesthesia
排除标准
- •Inadequate English comprehension due to a language barrier, cognitive deficit or intellectual disability
- •Epilepsy or other EEG abnormality
- •Prescription or illicit drugs known to affect the EEG
研究组 & 干预措施
1
0 ng/ml target effect site concentration remifentanil
干预措施: remifentanil (Drug)
2
2 ng/ml target concentration remifentanil
干预措施: remifentanil (Drug)
3
4 ng/ml target effect site concentration remifentanil
干预措施: remifentanil (Drug)
结局指标
主要结局
Prediction probability for prediction of anaesthetic endpoints
时间窗: During induction of anaesthesia
次要结局
未报告次要终点