Population Pharmacokinetics of Fentanyl in Patients Undergoing Living Donor Liver Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Population Pharmacokinetics of Fentanyl in Patients Undergoing Living Donor Liver Transplantation

Conditions
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Living Donor Liver Transplantation

Intervention / Treatment
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* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic parameters of fentanyl during LDLT | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LDLT