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

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ClinicalTrials.gov Identifier: NCT02827435
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Chul-Woo Jung, Seoul National University Hospital

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.


Condition or disease Intervention/treatment Phase
End Stage Renal Disease Transplantation Drug: Rocuronium bromide Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Acute Pharmacokinetic-pharmacodynamic Change of Rocuronium After Reperfusion of Renal Graft During Kidney Transplantation
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : January 28, 2019
Estimated Study Completion Date : July 28, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827435


Contacts
Contact: Chul-Woo Jung, MD. PhD 82-2-2072-0640 spss@dreamwiz.com
Contact: Eun-Jin Chung, MD quarkjin@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Chul-Woo Jung, MD. PhD    82-2-2072-2467    spss@snuh.org   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Chul-Woo Jung, MD. PhD Seoul National University Hospital

Responsible Party: Chul-Woo Jung, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02827435     History of Changes
Other Study ID Numbers: Roc_KTPL_PKPD
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Rocuronium
Bromides
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants