A Comparison of Propofol Based Total Intravenous Anesthesia and Desflurane Based Balanced Anesthesia on Hepatic Protection During Living-donor Liver Transplantation

July 3, 2017 updated by: Yonsei University
Renal ischemia/reperfusion (I/R)-induced injury is known to be associated with immediate and long-term hepatic dysfunction after liver transplantation. Protecting the liver against I/R injury and maintaining hepatic function during transplant surgery is therefore very important in order to improve post-operative outcome. This purpose of this study is to investigate whether propofol anesthesia done in both liver donors and recipients during living-donor liver transplantation is effective in reducing liver I/R injury via its antioxidant and antiinflammatory properties and improve post-transplant outcome compared to desflurane anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

(1) Adult liver donors and recipients scheduled for liver transplantation

Exclusion Criteria:

  1. Patient refusal
  2. Hypersensitivity to propofol, soybeans or peanuts
  3. History of vitamin C or E intake within 5 days before surgery
  4. History of acute myocardial infarct within 6 months before surgery
  5. Congestive heart failure (NYHA III-IV)
  6. Autoimmune disease patients
  7. BMI over 30 kg/m2
  8. Left ventricular ejection fraction less than 35% upon preoperative echocardiography

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Desflurane balanced anesthesia group
Drug: Desflurane balanced anesthesia
Desflurane balanced anesthesia induced with thiopental sodium, remifentanil and atracurium and maintained with remifentanil target controlled infusion and desflurane inhalation
Active Comparator: Propofol total intravenous anesthesia group
Drug: Propofol total intravenous anesthesia
Propofol total intravenous anesthesia induced with propofol, remifentanil and atracurium and maintained with remifentanil and propofol target controlled infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hepatic function
Time Frame: from 48hr before anesthesia, 1 hour after reperfusion, 1 hour after end of operation, every 24 hours daily up to 7 days postoperatively
The difference in hepatic function of recipients between groups after liver transplantation (PT, aPTT, albumin, bilirubin, platelet count, AST, ALT, lactate, triglyceride, ammonia)
from 48hr before anesthesia, 1 hour after reperfusion, 1 hour after end of operation, every 24 hours daily up to 7 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

July 13, 2015

First Submitted That Met QC Criteria

July 19, 2015

First Posted (Estimate)

July 21, 2015

Study Record Updates

Last Update Posted (Actual)

July 5, 2017

Last Update Submitted That Met QC Criteria

July 3, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0454

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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