Acute Pharmacokinetic-pharmacodynamic Change of Rocuronium After Reperfusion of Renal Graft During Kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- acceleromyography data (TOF ratio %)
研究概览
简要总结
Reperfusion of renal graft in kidney transplantation can change the pharmacokinetic-pharmacodynamic (PKPD) parameters of rocuronium. The immediate increase of urine output during surgery may change the PKPD parameters of the drugs, including elimination rate. The goal of this study is to characterize the PKPD model of rocuronium during kidney transplantation and establish a basis for adequate dosage of rocuronium in kidney transplantation.
Through PKPD modeling, the changes during reperfusion of the renal graft will be evaluated. Furthermore, the factors related to the changes will be assessed. Adjusting the infusion rate according to the step of kidney transplantation will lead to stable muscle relaxation and fast recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for elective living donor kidney transplantation
- •end stage renal disease with oliguria or anuria
- •normal BMI (BMI 18.5 ~ 25)
- •obtained informed consent
排除标准
- •patient with underlying neuromuscular disease
研究组 & 干预措施
Rocuronium bolus
rocuronium bromide 1st bolus 0.1mg/kg, rocuronium bromide 2nd bolus 0.4mg/kg
干预措施: Rocuronium bromide (Drug)
结局指标
主要结局
acceleromyography data (TOF ratio %)
时间窗: intraoperative
Muscle relaxation level (TOF, T1) will be evaluated via acceleromyography. The pharmacodynamic modeling with NONMEM throughout the kidney transplantation.
rocuronium plasma concentration (mcg/ml)
时间窗: 0, 1, 3, 5, 10, 30, 60, 90, 120 minutes after rocuronium second bolus injection
PKPD modeling from measuring plasma rocuronium concentration and excreted urine rocuronium amount
次要结局
未报告次要终点
研究者
Chul-Woo Jung
Associate professor
Seoul National University Hospital