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

NCT02827435 | Unknown

• 1 other identifier: Roc_KTPL_PKPD
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease; Transplantation

Outcome Measures

Primary Outcomes (2)

• rocuronium plasma concentration (mcg/ml)

  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 %)

  Muscle relaxation level (TOF, T1) will be evaluated via acceleromyography. The pharmacodynamic modeling with NONMEM throughout the kidney transplantation.

  intraoperative

Study Arms (1)

Rocuronium bolus

EXPERIMENTAL

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

Drug: Rocuronium bromide

Interventions

Rocuronium bromide DRUG

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

Rocuronium bolus

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• patient with underlying neuromuscular disease

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Chul-Woo Jung, MD. PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chul-Woo Jung, MD. PhD

CONTACT

82-2-2072-0640; spss@dreamwiz.com

Eun-Jin Chung, MD

CONTACT

quarkjin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: July 11, 2016
• Study Start: July 1, 2016
• Primary Completion: July 31, 2019
• Study Completion: December 31, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)