Population Pharmacokinetics of Fentanyl in Patients Undergoing Living Donor Liver Transplantation

June 21, 2011 updated by: Asan Medical Center
The aim of this study was to characterize pharmacokinetics of fentanyl during and after Living Donor Liver Transplantation (LDLT), using population pharmacokinetic analysis with non linear mixed effects modeling.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients received an initial intravenous bolus of fentanyl 100 μg and infused at variable rates ranging from 250 to 400 μg/hr.

Arterial blood samples (3ml) were taken immediately before the start of infusion (baseline), and at scheduled time which were coincident with laboratory tests during surgery as follows. In pre-anhepatic phase, blood were taken at 10min, 30min, 1hr, 3hr, 5hr until clamping of the hepatic blood supply and venous drainage, after the star of anhepatic phase, blood were taken at 5 min, 10 min, 30 min, 60 min, 90 min, 2hr until the vessels were reconnected to new liver. In neo-hepatic phase, blood were taken at 5min, 10min, 30min, 60min, 90min, 2hr, 3hr, 5hr until fentanyl-infusion stop, and at 0hr, 1hr, 3hr, 5hr, 8hr, 12hr, 24hr immediately after the stop of infusion. Samples were collected into tubes containing heparin as an anticoagulant and immediately placed on ice. After centrifugation for 8 min at 1800 g, the plasma was transferred to a cryovial and stored at -70°C until assay.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between 19 - 65 years of age
  • Over 45kg of weight
  • Written Informed consent
  • Patients receiving a liver graft from living donor (ASA PS III or IV)

Exclusion Criteria:

  • Patients with renal dysfunction
  • Patients with Fulminant hepatic failure
  • Patients participated other clinical trials within 2 months
  • Unable or Unwilling to give informed consent
  • Abnormal test results with clinical significance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pharmacokinetics of fentanyl
Drug: Fentanyl
an initial intravenous bolus of fentanyl 100 μg and infusion of fentanyl at variable rates ranging from 250 to 400 μg/hr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pharmacokinetic parameters of fentanyl during LDLT
Time Frame: 48 Hours (during anesthesia of LT and after infusion stop)
characterize pharmacokinetics of fentanyl during and after LDLT, using population pharmacokinetic analysis with non-linear mixed effects modeling.
48 Hours (during anesthesia of LT and after infusion stop)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Ministry of Health & Welfare, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

June 14, 2010

First Submitted That Met QC Criteria

June 14, 2010

First Posted (Estimate)

June 15, 2010

Study Record Updates

Last Update Posted (Estimate)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-0534 (Other Identifier: Asan Medical Center IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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