Back to resultsA Comparison of Propofol Based Total Intravenous Anesthesia and Desflurane Based Balanced Anesthesia on Hepatic Protection During Living-donor Liver Transplantation
Primary Purpose
End Stage Liver Disease
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Desflurane balanced anesthesia
Propofol total intravenous anesthesia
Sponsored by
About this trial
This is an interventional prevention trial for End Stage Liver Disease
Eligibility Criteria
Inclusion Criteria:
(1) Adult liver donors and recipients scheduled for liver transplantation
Exclusion Criteria:
- 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
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Desflurane balanced anesthesia group
Propofol total intravenous anesthesia group
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02504138
Brief Title
A Comparison of Propofol Based Total Intravenous Anesthesia and Desflurane Based Balanced Anesthesia on Hepatic Protection During Living-donor Liver Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Liver Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desflurane balanced anesthesia group
Arm Type
Experimental
Arm Title
Propofol total intravenous anesthesia group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Desflurane balanced anesthesia
Intervention Description
Desflurane balanced anesthesia induced with thiopental sodium, remifentanil and atracurium and maintained with remifentanil target controlled infusion and desflurane inhalation
Intervention Type
Drug
Intervention Name(s)
Propofol total intravenous anesthesia
Intervention Description
Propofol total intravenous anesthesia induced with propofol, remifentanil and atracurium and maintained with remifentanil and propofol target controlled infusion
Primary Outcome Measure Information:
Title
hepatic function
Description
The difference in hepatic function of recipients between groups after liver transplantation (PT, aPTT, albumin, bilirubin, platelet count, AST, ALT, lactate, triglyceride, ammonia)
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(1) Adult liver donors and recipients scheduled for liver transplantation
Exclusion Criteria:
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
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
31083000
Citation
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.
Results Reference
derived
Learn more about this trial
A Comparison of Propofol Based Total Intravenous Anesthesia and Desflurane Based Balanced Anesthesia on Hepatic Protection During Living-donor Liver Transplantation
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