Propofol Measurement in Expiration Air and Monitoring of EEG and Pain in Patients Undergoing Low Back Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Exhaled air versus plasma concentration
研究概览
简要总结
Edmon (BBraun, Germany) is a portable, commercially available device for measurement of propofol in exhaled air.
The study will aim at evaluating the sensitivity and specificity of such exhaled propofol values compared with plasma propofol and measures of anaesthetic and antinociceptive effect.
详细描述
Elective low-back surgery patients will be induced for general intubation anesthesia with propofol and remifentanil.
After induction a 20 min period of stable propofol infusion only will be established before start of surgery. The patients will be monitored for exhaled propofol, plasma propofol (blood samples), continous frontal EEG, Bispectral Index (BIS), skin conductance, estimated (computer based) concentrations of plasma and effect site propofol, and skin conductance.
After start of surgery (with ongoing propofol and restart of remifentanil TCI) the monitoring will continue in order to explore these relationships further.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective patients scheduled for low-back surgery
- •BMI between 20 -32 kg/m2
- •Written informed concent
排除标准
- •Contraindication to propofol TCI
- •Use of psychopharmaco or neurologic disease
- •Pregnancy or breast feeding
结局指标
主要结局
Exhaled air versus plasma concentration
时间窗: per-operative
次要结局
- Exhaled propofol 2(per-operative)
- Nociceptive stimulation(per-operative)
- EEG recording(per-operative)
研究者
Johan C Ræder
Professor
Oslo University Hospital