Population Pharmacokinetics of Fentanyl in Patients Undergoing Living Donor Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- pharmacokinetic parameters of fentanyl during LDLT
研究概览
简要总结
The aim of this study was to characterize pharmacokinetics of fentanyl during and after Living Donor Liver Transplantation (LDLT), using population pharmacokinetic analysis with non linear mixed effects modeling.
详细描述
Patients received an initial intravenous bolus of fentanyl 100 μg and infused at variable rates ranging from 250 to 400 μg/hr.
Arterial blood samples (3ml) were taken immediately before the start of infusion (baseline), and at scheduled time which were coincident with laboratory tests during surgery as follows. In pre-anhepatic phase, blood were taken at 10min, 30min, 1hr, 3hr, 5hr until clamping of the hepatic blood supply and venous drainage, after the star of anhepatic phase, blood were taken at 5 min, 10 min, 30 min, 60 min, 90 min, 2hr until the vessels were reconnected to new liver. In neo-hepatic phase, blood were taken at 5min, 10min, 30min, 60min, 90min, 2hr, 3hr, 5hr until fentanyl-infusion stop, and at 0hr, 1hr, 3hr, 5hr, 8hr, 12hr, 24hr immediately after the stop of infusion. Samples were collected into tubes containing heparin as an anticoagulant and immediately placed on ice. After centrifugation for 8 min at 1800 g, the plasma was transferred to a cryovial and stored at -70°C until assay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 19 - 65 years of age
- •Over 45kg of weight
- •Written Informed consent
- •Patients receiving a liver graft from living donor (ASA PS III or IV)
排除标准
- •Patients with renal dysfunction
- •Patients with Fulminant hepatic failure
- •Patients participated other clinical trials within 2 months
- •Unable or Unwilling to give informed consent
- •Abnormal test results with clinical significance
研究组 & 干预措施
pharmacokinetics of fentanyl
干预措施: Fentanyl (Drug)
结局指标
主要结局
pharmacokinetic parameters of fentanyl during LDLT
时间窗: 48 Hours (during anesthesia of LT and after infusion stop)
characterize pharmacokinetics of fentanyl during and after LDLT, using population pharmacokinetic analysis with non-linear mixed effects modeling.
次要结局
未报告次要终点
