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

Acute Pharmacokinetic-pharmacodynamic Change of Rocuronium After Reperfusion of Renal Graft During Kidney Transplantation

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02827435

Enrollment

Registered

2016-07-11

Start date

2016-07-01

Completion date

2024-12-31

Last updated

2023-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Transplantation

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.

Interventions

DRUGRocuronium bromide

Pharmacokinetic-pharmacodynamic modeling blood sampling and Rocuronium bromide concentration measure muscle relaxation evaluation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
acceleromyography data (TOF ratio %)	intraoperative	Muscle relaxation level (TOF, T1) will be evaluated via acceleromyography. The pharmacodynamic modeling with NONMEM throughout the kidney transplantation.

Countries

South Korea

Contacts

Primary ContactChul-Woo Jung, MD. PhD

spss@dreamwiz.com82-2-2072-0640

Backup ContactEun-Jin Chung, MD

quarkjin@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026