NCT01144312

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

June 22, 2011

Status Verified

June 1, 2010

Enrollment Period

1 year

First QC Date

June 14, 2010

Last Update Submit

June 21, 2011

Conditions

Living Donor Liver Transplantation

Keywords

LDLT

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

pharmacokinetics of fentanyl

EXPERIMENTAL
Drug: Fentanyl

Interventions

FentanylDRUG

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

pharmacokinetics of fentanyl

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 14, 2010

First Posted

June 15, 2010

Study Start

September 1, 2009

Primary Completion

September 1, 2010

Study Completion

October 1, 2010

Last Updated

June 22, 2011

Record last verified: 2010-06

Locations

KR(1)