Expiratory and Plasma Propofol Concentration in Bariatric and Cholecystectomy Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- exhaled propofol concentration
研究概览
简要总结
Determination of accuracy With Edmond (reg) expiratory propofol measurement Device, compared With concommitant plasma samples of propofol
详细描述
Edmon (trade mark) is a New Device from BBraun, measuring the expiratory concentration of propofol in anaesthetized patients.
The investigators will test the accuracy and stability of such measurements in comparison With plasma propofol Levels.
The investigators will test during target Control infusion (Marsh model) and assumed stable plasma Levels.
Plasma samples of propofol will be taken for comparison With exhaled propofol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •• Patients admitted to Oslo University Hospital, scheduled for elective laparoscopic bariatric surgery or elective laparoscopic cholecystectomy.
- •Both genders.
- •Age 18-60 years, both inclusive.
- •BMI ≥ 20 kg/m2, 10 patients with BMI 20-30, and 10 patients with BMI > 40
- •ASA classification I-III
排除标准
- •• Known hypersensitivity or other contraindication to propofol administered as Target Controlled Infusion.
- •Patients which during a preoperative visit are deemed not to tolerate propofol bolus or infusion as administered by Target Controlled Infusion.
- •Ongoing neuroleptic medication.
研究组 & 干预措施
Bariatric surgery
Patients due for bariatric surgery, BMI > 30
干预措施: Edmon (reg), BBraun (Device)
Cholecystectomy
Normal weight patients due for cholecystectomies
干预措施: Edmon (reg), BBraun (Device)
结局指标
主要结局
exhaled propofol concentration
时间窗: start of anaesthesia to end of anaesthesia, 2-3 hours in total
parts per billion
propofol plasma concentration
时间窗: 4-6 samples in the period between start and end of anaesthesia
microg pr ml
次要结局
- calculated plasma concentration(From start of anaesthesia until end of anaesthesia, 1-3 hrs in total)
- BIS(from start of anaesthesia until end of anaestheisa, 1-3 hours in total)
- calculated effect site concentration(from start of anaesthesia until end of anaesthesia, 1-3 hours in total)
- EEG Power spectrum(f)
- EEG Power distribution(from start of anaesthesia until end of anaesthesia, 1-3 hours in total)
研究者
Johan C Ræder
Professor
Oslo University Hospital