Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT00994981 - Magnesium Administration in Liver Transplantation and Reperfusion Injury Phase 4
Not yet recruiting NCT04988100 - Impact of Splenic Artery Ligation in LDLT for Patients With Portal Hypertension N/A
Completed NCT05506020 - Application of ICG Fluorescence Cholangiography in Laparoscopic Living Donor Left Lateral Sectionectomy N/A
Recruiting NCT05431361 - PRehab tO PreparE Living Liver Donors for Enhanced Recovery N/A
Recruiting NCT04909645 - A Comparison of Invasive and Non-invasive Measurement of CI and SVR in Liver Transplantation N/A
Recruiting NCT01907750 - Transcystic Versus Transanastomotic Tube Drainage in Right Lobe LDLT Phase 3
Completed NCT04184401 - Effect of Ascites Replacement Strategy on Time to 1st Flatus After LDLT Phase 4
Completed NCT02990351 - Efficacy of Loco-regional Treatment for Hepatocellular Carcinoma Prior to Living Donor Liver Transplantation in Egypt N/A
Active, not recruiting NCT04208919 - Delayed Infusion of DCreg in Living Donor Liver Transplantation Phase 1/Phase 2
Completed NCT03773276 - Norepinephrine Boluses in Liver Transplantation Phase 1/Phase 2
Active, not recruiting NCT03164265 - DCreg in Living Donor Liver Transplantation Phase 1/Phase 2
Completed NCT05010941 - Hypotension Prediction Index in Living Donor Liver Transplantation
Not yet recruiting NCT04943263 - A Comparison of Temperature Measurement During Living Donor Liver Transplantation N/A