Population Pharmacokinetics of Fentanyl in Patients Undergoing Living Donor Liver Transplantation

Living Donor Liver Transplantation Clinical Trial

Official title:

Population Pharmacokinetics of Fentanyl in Patients Undergoing Living Donor Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144312
• Other study ID #: 2009-0534
• Secondary ID: 2009-0534
• Status: Completed
• Phase: N/A
• First received: June 14, 2010
• Last updated: June 21, 2011
• Start date: September 2009
• Est. completion date: October 2010

Study information

• Verified date: June 2010
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Living Donor Liver Transplantation

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No