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NCT02827435 Clinical Trial

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

End Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02827435
Other study ID # Roc_KTPL_PKPD
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2016
Est. completion date December 31, 2024

Study information
Verified date November 2023
Source Seoul National University Hospital
Contact Chul-Woo Jung, MD. PhD
Phone 82-2-2072-0640
Email spss@dreamwiz.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 12
Est. completion date December 31, 2024
Est. primary completion date July 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary acceleromyography data (TOF ratio %) Muscle relaxation level (TOF, T1) will be evaluated via acceleromyography. The pharmacodynamic modeling with NONMEM throughout the kidney transplantation. intraoperative
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