A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- plasma drug concentration of propofol
研究概览
简要总结
This study will determine how morbid obesity affects the distribution and metabolism of the drug propofol. The investigators hypothesize that propofol will be distributed and metabolized differently in morbidly obese subjects as compared to normal weight subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult age (ages 18-70)
- •body mass index greater than 40 or between 20-25
- •American Society of Anesthesiologists Class I, II, or III
- •undergoing elective surgical procedure requiring general anesthesia
排除标准
- •evidence of cardiovascular or pulmonary disease
- •kidney or liver dysfunction
- •drug allergy to propofol
- •history of difficult airway
- •on prescribed or over the counter anxiolytics, antipsychotics, or sleeping aids
- •unable to speak or understand English
研究组 & 干预措施
Morbidly obese subjects
Morbidly obese subjects (body mass index greater than 40) will be given propofol for induction of general anesthesia. Plasma samples will be taken to ascertain drug concentration over time.
干预措施: propofol (Drug)
Control subjects (body mass index 20-25)
Normal weight subjects (body mass index 20-25) will be given propofol during induction of general anesthesia. Plasma samples will be collected over time to ascertain propofol plasma concentration.
干预措施: propofol (Drug)
结局指标
主要结局
plasma drug concentration of propofol
时间窗: measured during the perioperative period
Plasma concentration over time will be measured and modeled in order to calculate drug clearance, volume of distribution, area under the curve, and micro rate constants. Knowledge of these variables will allow safer administration of anesthetic drug administration in the obese population. Knowledge of these parameters will allow propofol to be administered safely in morbily obese subjects.
次要结局
未报告次要终点
研究者
Jerry Ingrande
Principal Investigator
Stanford University