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

End Stage Liver Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504138
• Other study ID #: 4-2013-0454
• Status: Completed
• Phase: Phase 4
• First received: July 13, 2015
• Last updated: July 3, 2017
• Start date: June 2014
• Est. completion date: May 2017

Study information

• Verified date: July 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Liver Disease
• Liver Diseases

Intervention

Drug:
• Desflurane balanced anesthesia
Desflurane balanced anesthesia induced with thiopental sodium, remifentanil and atracurium and maintained with remifentanil target controlled infusion and desflurane inhalation
• Propofol total intravenous anesthesia
Propofol total intravenous anesthesia induced with propofol, remifentanil and atracurium and maintained with remifentanil and propofol target controlled infusion

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hepatic function	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