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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02504138
Enrollment
136
Registered
2015-07-21
Start date
2014-06-30
Completion date
2017-05-31
Last updated
2017-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Liver Disease

Brief summary

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.

Interventions

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

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
hepatic functionfrom 48hr before anesthesia, 1 hour after reperfusion, 1 hour after end of operation, every 24 hours daily up to 7 days postoperativelyThe difference in hepatic function of recipients between groups after liver transplantation (PT, aPTT, albumin, bilirubin, platelet count, AST, ALT, lactate, triglyceride, ammonia)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026