Propofol Effect-Site Target Controlled Infusion in the Obese: Characterization of the Time Profile of Bispectral Index Response.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Profile of Pharmacokinetic and Pharmacodynamic of an induction bolus dose of propofol in obese patients.
研究概览
简要总结
The aim of this study is to characterize the Pharmacokinetic/Pharmacodynamic relationship of a single bolus dose of propofol in obese patients and to extract a time to peak effect (t-peak) from the estimated model parameters.
详细描述
Target controlled infusion (TCI) is a technique to administer intravenous drugs that allows rapid achievement and maintenance of predetermined drug concentrations, either in plasma (Cp) or at the site of effect (Ce).
To characterize the time profile of propofol effect an additional parameter, the equilibration half time between plasma and effect site (T1/2keo) needs to be incorporated in the pharmacokinetic (PK) model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •IMC > 35 kg m-2
- •Scheduled for laparoscopic bariatric surgery
- •ASA I-II patients
- •Between 20 and 60 yr of age.
排除标准
- •Patients with allergy to study drugs
- •Uncontrolled hypertension
- •Heart block greater than first degree
- •Take any drug acting in the central nervous system
研究组 & 干预措施
Propofol
14 obese patients(IMC>35 kg m-2) scheduled for laparoscopic bariatric surgery
干预措施: Propofol (Drug)
结局指标
主要结局
Profile of Pharmacokinetic and Pharmacodynamic of an induction bolus dose of propofol in obese patients.
时间窗: 1, 2, 3, 5, 7 and 10 minutes after the initial bolus dose or until BIS > 75
Pharmacokinetic parameters (V1, V2, V3, CL, Q) Pharmacodynamic parameters (E0, Emax, C50, Gamma, t1/2Ke0, T peak )
次要结局
未报告次要终点
研究者
Pablo Sepulveda
Profesor Asociado Anestesiología
Universidad del Desarrollo