Prospective Multicenter Open-Label Single Group Study on the Comparison Between Propofol Concentration in Exhaled Breath and Blood Plasma Using the Propofol Monitor Edmon in Patients Undergoing Elective Surgery Under Total Intravenous Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Propofol measurements
研究概览
简要总结
Edmon is the first Communauté Européenne (CE) marked medical device able to continuously measure propofol in the exhaled breath of patients under sedation or anaesthesia with propofol. Current scientific publications indicate that it makes sense from a pharmacologic point of view to measure propofol in the exhaled air.
If the present study can show the Edmon to be able to detect small differences in propofol plasma concentration it will underline the clinical value of measuring propofol in the exhaled breath. This might be an opportunity for a significant improvement in patient monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Inclusion criteria
- •Male or female patients undergoing elective surgical procedures
- •Expected duration of the surgical procedure > 1h
- •General anaesthesia (TIVA) with propofol and remifentanil under orotracheal intubation
- •Medical need for an arterial line for an invasive haemodynamic monitoring during anaesthesia
- •Written informed consent
- •Age ≥ 18 years
- •ASA I-III
- •BMI < 35 kg/m²
- •Women of child bearing potential: negative pregnancy test
- •BIS monitoring feasible (e.g. no surgical procedures on the frontal brain)
- •The patient is expected to be extubated in the OR after end of surgery
排除标准
- •Patients with contraindications for propofol, remifentanil or for the planned anaesthetic procedure
- •Cardiac surgery
- •Lung surgery
- •Organ transplant procedures
- •Pulmonary diffusion anomalies (e.g. pulmonary fibrosis), known from medical history
- •Patients on renal replacement therapy
- •Participation in another interventional trial
- •Breastfeeding women
- •Unilateral lung ventilation
- •Emergency surgery
- •Patient is not able to give his/her written informed consent
- •Patients with a haemoglobin level below 10 g/dl
研究组 & 干预措施
Exhaled drug monitor "Edmon"
Comparison between propofol in exhaled breath and blood plasma
干预措施: Exhaled drug monitor "Edmon" (Device)
结局指标
主要结局
Propofol measurements
时间窗: During elective surgical procedure lasting longer than 1 hour
To investigate the correlation between propofol concentrations in exhaled breath and blood plasma in patients undergoing elective surgical procedures under total intravenous anaesthesia.
次要结局
- Identification of confounders with an impact on propofol exhaled breath concentration, e.g.among ventilatory and circulatory parameters(During elective surgical procedure lasting longer than 1 hour)
- Evaluation of the correlation between propofol exhaled breath concentration and EEG index values(During elective surgical procedure lasting longer than 1 hour)