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

November 29, 2023 updated by: Chul-Woo Jung, Seoul National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Chul-Woo Jung, MD. PhD
          • Phone Number: 82-2-2072-2467
          • Email: spss@snuh.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rocuronium plasma concentration (mcg/ml)
Time Frame: 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
0, 1, 3, 5, 10, 30, 60, 90, 120 minutes after rocuronium second bolus injection
acceleromyography data (TOF ratio %)
Time Frame: intraoperative
Muscle relaxation level (TOF, T1) will be evaluated via acceleromyography. The pharmacodynamic modeling with NONMEM throughout the kidney transplantation.
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

July 31, 2019

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

July 8, 2016

First Posted (Estimated)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Roc_KTPL_PKPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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