Modelling Propofol Pharmacokinetics and Pharmacodynamics During an Intravenous Anaesthesia Guided by the Bispectral Index (BIS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Plasma Propofol Concentration (mcg/mL)
研究概览
简要总结
The main purpose of this research is to develop a population pharmacokinetic and pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia, using BIS as a pharmacodynamic endpoint.
A covariate analysis will be performed in order to account for variability in pharmacokinetic and pharmacodynamic parameters. The influence of age and obesity on propofol pharmacokinetic parameters will be particularly addressed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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 admitted for nose or ear surgery, bariatric surgery or urgent orthopaedic surgery.
排除标准
- •Severe hepatic or renal insufficiency;
- •Significant haemodynamic instability previous to the surgery;
- •Allergy to eggs or propofol at the time of enrolment;
- •Predictive criteria for difficult airway management.
研究组 & 干预措施
Group 1 (≥18 years, BMI<35kg/m2)
Patients with 18 or more years presenting for inpatient nose and ear surgery.
干预措施: Propofol (Drug)
Group 2 (≥18 years, ≥35kg/m2)
Patients with 18 or more years presenting for inpatient bariatric surgery.
干预措施: Propofol (Drug)
Group 3 (≥65 years)
Patients with 65 or more years presenting for orthopaedic surgery.
干预措施: Propofol (Drug)
结局指标
主要结局
Plasma Propofol Concentration (mcg/mL)
时间窗: up to 2 hours
Arterial blood samples were obtained after LOC and every 20-30 minutes during propofol infusion. After stopping propofol infusion, arterial blood samples were obtained immediately after recovery of consciousness. At the end of the surgery arterial blood samples were centrifuged at 2862xg for 5 minutes and they were preserved at -80ºC until analysis. The quantification of propofol in serum was performed using gas chromatography/ion trap-mass spectrometry (GC/IT-MS)
次要结局
未报告次要终点
研究者
Ana M Araujo
MD
Centro Hospitalar do Porto