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Completed

NCT Number: NCT01144312

Population Pharmacokinetics of Fentanyl in Patients Undergoing Living Donor Liver Transplantation

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.

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Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Drug

an initial intravenous bolus of fentanyl 100 μg and infusion of fentanyl at variable rates ranging from 250 to 400 μg/hr

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Ministry of Health & Welfare, Korea

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 15, 2010
Registry last updated
Jun 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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