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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT02827435

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease Transplantation	Drug: Rocuronium bromide	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Jul 31, 2019

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rocuronium bolus rocuronium bromide 1st bolus 0.1mg/kg, rocuronium bromide 2nd bolus 0.4mg/kg	Drug: Rocuronium bromide Pharmacokinetic-pharmacodynamic modeling blood sampling and Rocuronium bromide concentration measure muscle relaxation evaluation

Arm

Intervention/Treatment

Experimental: Rocuronium bolus

rocuronium bromide 1st bolus 0.1mg/kg, rocuronium bromide 2nd bolus 0.4mg/kg

Drug: Rocuronium bromide

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Chul-Woo Jung, MD. PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chul-Woo Jung, Associate professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT02827435

Other Study ID Numbers:

Roc_KTPL_PKPD

First Posted:

Jul 11, 2016

Last Update Posted:

Jun 22, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Kidney Failure, Chronic

Bromides

Rocuronium

Study Results

No Results Posted as of Jun 22, 2022