Population Pharmacokinetics of Fentanyl in Patients Undergoing Living Donor Liver Transplantation

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health & Welfare, Korea
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01144312
First received: June 14, 2010
Last updated: June 21, 2011
Last verified: June 2010
  Purpose

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.


Condition Intervention
Living Donor Liver Transplantation
Drug: Fentanyl

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Population Pharmacokinetics of Fentanyl in Patients Undergoing Living Donor Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • pharmacokinetic parameters of fentanyl during LDLT [ Time Frame: 48 Hours (during anesthesia of LT and after infusion stop) ] [ Designated as safety issue: No ]
    characterize pharmacokinetics of fentanyl during and after LDLT, using population pharmacokinetic analysis with non-linear mixed effects modeling.


Estimated Enrollment: 20
Study Start Date: September 2009
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144312

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Ministry of Health & Welfare, Korea
  More Information

No publications provided

Responsible Party: Myung Hee Song/Assistant clinical professor, Department of Anesthesiology and Pain Medicine, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01144312     History of Changes
Other Study ID Numbers: 2009-0534, 2009-0534
Study First Received: June 14, 2010
Last Updated: June 21, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
LDLT

Additional relevant MeSH terms:
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 28, 2014