Acute Pharmacokinetic-pharmacodynamic Change of Rocuronium After Reperfusion of Renal Graft

Not Applicable

Recruiting

• Conditions: End Stage Renal Disease; Transplantation
• Interventions: Drug: Rocuronium bromide

• Registration Number: NCT02827435
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-14
• Study Start: 2016-07-01
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-11
• Primary Completion: 2019-07-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 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

Exclusion Criteria

• patient with underlying neuromuscular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rocuronium bolus	Rocuronium bromide	rocuronium bromide 1st bolus 0.1mg/kg, rocuronium bromide 2nd bolus 0.4mg/kg

Primary Outcome Measures

Name	Time	Method
acceleromyography data (TOF ratio %)	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)	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of