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临床试验/NCT02477982
NCT02477982已完成不适用

Influence of Obesity on Propofol Pharmacokinetics During Cardiac Surgeries Using Cardiopulmonary Bypass: Derivation of a Pharmacokinetic Model

Cairo University0 个研究点目标入组 34 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
主要终点
Clearance (Cl/)

研究概览

简要总结

The primary objective of this study is to develop a descriptive and predictive pharmacokinetics model propofol disposition during cardiopulmonary bypass (CPB) in obese and lean patients.

详细描述

Anaesthesia maintenance upon initiation of CPB will be achieved by propofol (1%) bolus (1 mg/kg TBW) immediately followed by 2 mg/kg TBW/hr infusion that will be continued till weaning from CPB. During CPB an additional propofol bolus doses can be administered to prevent awareness according to the clinical judgment of the responsible anaesthesiologist. Any additional doses given and their timings will be recorded.

Blood samples of 2 ml each will be collected from the arterial line of CPB machine until the end of CPB then from sub-clavin arterial catheter routinely inserted in such surgeries. Sampling process will follow the following schedule; at baseline prior to dosing, followed by samples at 1, 3, 5,7 min after the propofol bolus dose, then every 20 minutes during propofol infusion, just before discontinuation of the propofol infusion and at 1, 3, 5, 7, 10, 20, 30, 60 minutes after the end of infusion. In addition, just before any rescue propofol dose administration, an unscheduled sample will be withdrawn

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI ≤ 25 kg/m2 or ≥ 30 kg/m
  • Propofol based maintenance of anaesthesia during CPB.

排除标准

  • Pregnant women or lactating mothers.
  • Renal (serum creatinine concentration>1.5 or creatinine Cl ≤ 30 ml/min) or hepatic disorders (total bilirubin >1.5 or ≥ 2 fold increase in alanine transferase (ALT) or aspartate transferase (AST).
  • Systemic infections.
  • Hypoalbuminemia (defined as albumin <3.5 gm/dL).
  • Known history of alcohol or drug abuse.
  • Administration of aspirin on the day of surgery or warfarin within 7 days preceding surgery

结局指标

主要结局

Clearance (Cl/)

时间窗: intraoperative

Clearance from first to second compartment (Q1)

时间窗: intraoperative

volume of distribution of second compartment (V1)

时间窗: intraoperative

volume of distribution of first compartment (V1)

时间窗: intraoperative

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eman Ali Ali

Teaching assistant at clinical pharmacy department faculty of pharmacy

Cairo University

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