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

Primary Purpose

End Stage Renal Disease, Transplantation

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rocuronium bromide
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for End Stage Renal Disease

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rocuronium bolus

Arm Description

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

Outcomes

Primary Outcome Measures

rocuronium plasma concentration (mcg/ml)
PKPD modeling from measuring plasma rocuronium concentration and excreted urine rocuronium amount
acceleromyography data (TOF ratio %)
Muscle relaxation level (TOF, T1) will be evaluated via acceleromyography. The pharmacodynamic modeling with NONMEM throughout the kidney transplantation.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2016
Last Updated
June 20, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02827435
Brief Title
Acute Pharmacokinetic-pharmacodynamic Change of Rocuronium After Reperfusion of Renal Graft
Official Title
Acute Pharmacokinetic-pharmacodynamic Change of Rocuronium After Reperfusion of Renal Graft During Kidney Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Transplantation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rocuronium bolus
Arm Type
Experimental
Arm Description
rocuronium bromide 1st bolus 0.1mg/kg, rocuronium bromide 2nd bolus 0.4mg/kg
Intervention Type
Drug
Intervention Name(s)
Rocuronium bromide
Intervention Description
Pharmacokinetic-pharmacodynamic modeling blood sampling and Rocuronium bromide concentration measure muscle relaxation evaluation
Primary Outcome Measure Information:
Title
rocuronium plasma concentration (mcg/ml)
Description
PKPD modeling from measuring plasma rocuronium concentration and excreted urine rocuronium amount
Time Frame
0, 1, 3, 5, 10, 30, 60, 90, 120 minutes after rocuronium second bolus injection
Title
acceleromyography data (TOF ratio %)
Description
Muscle relaxation level (TOF, T1) will be evaluated via acceleromyography. The pharmacodynamic modeling with NONMEM throughout the kidney transplantation.
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chul-Woo Jung, MD. PhD
Phone
82-2-2072-0640
Email
spss@dreamwiz.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eun-Jin Chung, MD
Email
quarkjin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chul-Woo Jung, MD. PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chul-Woo Jung, MD. PhD
Phone
82-2-2072-2467
Email
spss@snuh.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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