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

NCT ID: NCT02504138

Last Updated: 2017-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End Stage Liver Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Desflurane balanced anesthesia group

Group Type EXPERIMENTAL

Desflurane balanced anesthesia

Intervention Type DRUG

Desflurane balanced anesthesia induced with thiopental sodium, remifentanil and atracurium and maintained with remifentanil target controlled infusion and desflurane inhalation

Propofol total intravenous anesthesia group

Group Type ACTIVE_COMPARATOR

Propofol total intravenous anesthesia

Intervention Type DRUG

Propofol total intravenous anesthesia induced with propofol, remifentanil and atracurium and maintained with remifentanil and propofol target controlled infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Desflurane balanced anesthesia

Desflurane balanced anesthesia induced with thiopental sodium, remifentanil and atracurium and maintained with remifentanil target controlled infusion and desflurane inhalation

Intervention Type DRUG

Propofol total intravenous anesthesia

Propofol total intravenous anesthesia induced with propofol, remifentanil and atracurium and maintained with remifentanil and propofol target controlled infusion

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

Shin S, Joo DJ, Kim MS, Bae MI, Heo E, Lee JS, Kim DW, Yoo YC. Propofol intravenous anaesthesia with desflurane compared with desflurane alone on postoperative liver function after living-donor liver transplantation: A randomised controlled trial. Eur J Anaesthesiol. 2019 Sep;36(9):656-666. doi: 10.1097/EJA.0000000000001018.

Reference Type DERIVED
PMID: 31083000 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4-2013-0454

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Reduction of Remifentanil-related Complications
NCT01003028 NOT_YET_RECRUITING PHASE4