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

NCT02504138 | Completed Phase 4

• 1 other identifier: 4-2013-0454
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Desflurane balanced anesthesia group

EXPERIMENTAL

Drug: Desflurane balanced anesthesia

Propofol total intravenous anesthesia group

ACTIVE COMPARATOR

Drug: Propofol total intravenous anesthesia

Interventions

Desflurane balanced anesthesia DRUG

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

Desflurane balanced anesthesia group

Propofol total intravenous anesthesia DRUG

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

Propofol total intravenous anesthesia group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 120-752, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31083000 DERIVED

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 21, 2015
• Study Start: June 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 5, 2017

Record last verified: 2017-07

Locations

KR (1)