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

NCT ID: NCT02827435

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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End Stage Renal Disease Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Rocuronium bolus

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

Group Type EXPERIMENTAL

Rocuronium bromide

Intervention Type DRUG

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

Interventions

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Rocuronium bromide

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chul-Woo Jung

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chul-Woo Jung, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Chul-Woo Jung, MD. PhD

Role: CONTACT

Phone: 82-2-2072-0640

Email: [email protected]

Eun-Jin Chung, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Chul-Woo Jung, MD. PhD

Role: primary

Other Identifiers

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Roc_KTPL_PKPD

Identifier Type: -

Identifier Source: org_study_id