Population Pharmacokinetics of Fentanyl in Patients Undergoing Living Donor Liver Transplantation
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|ClinicalTrials.gov Identifier: NCT01144312|
Recruitment Status : Completed
First Posted : June 15, 2010
Last Update Posted : June 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Living Donor Liver Transplantation||Drug: Fentanyl||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Population Pharmacokinetics of Fentanyl in Patients Undergoing Living Donor Liver Transplantation|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||October 2010|
|Experimental: pharmacokinetics of fentanyl||
an initial intravenous bolus of fentanyl 100 μg and infusion of fentanyl at variable rates ranging from 250 to 400 μg/hr
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144312
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|