Back to resultsThe Comparison of Changes of QTc, Tp-e Interval, and Tp-e/QT Ratio, Tp-e/QTc Ratio on the ECG During Living Donor Liver Transplantation Under Desflurane and Total Intravenous Anesthesia -Randomized Controlled Trial
Primary Purpose
Liver Cirrhosis(Who Will Undergo Planed Liver Transplantation)
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
inhalation (desflurane) group
total intravenous (propofol) anesthesia
Sponsored by
About this trial
This is an interventional other trial for Liver Cirrhosis(Who Will Undergo Planed Liver Transplantation)
Eligibility Criteria
Inclusion Criteria:
- patients with liver cirrhosis who will undergo planned liver transplantation
Exclusion Criteria:
- 1. emergent liver transplantation
- 2. unstable angina
- 3. recent MI(Myocardial Infarction)
- 4. uncontrolled hypertension (diastolic BP > 110mmHg)
- 5. implantable cardiac defibrillator
- 6. severe obesity (BMI>30kg/m2)
- 7. allergy to propofol
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
inhalation anesthesia (desflurane) group
Total intravenous anesthesia (propofol) group
Arm Description
Anesthesia is induced and maintained with desflurane and sufentanil
Anesthesia is induced and maintained with propofol and sufentanil
Outcomes
Primary Outcome Measures
QTc interval
The investigator will assess the QTc interval 3 minutes after the reperfusion during liver transplantation.
Secondary Outcome Measures
QTc interval
The investigator will assess the QTc interval at the end of liver transplantation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03864276
Brief Title
The Comparison of Changes of QTc, Tp-e Interval, and Tp-e/QT Ratio, Tp-e/QTc Ratio on the ECG During Living Donor Liver Transplantation Under Desflurane and Total Intravenous Anesthesia -Randomized Controlled Trial
Official Title
The Comparison of Changes of QTc, Tp-e Interval, and Tp-e/QT Ratio, Tp-e/QTc Ratio on the ECG During Living Donor Liver Transplantation Under Desflurane and Total Intravenous Anesthesia -Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 17, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prolonged corrected QT interval (QTc) has been observed in about half of patients with liver cirrhosis. Marked prolongation of QTc (ie, 500 msec) has been considered to be a risk factor for fatal ventricular arrhythmia, such as torsade de pointes,7,8 which has been reported in liver transplantation (LT) surgery. In a previous study, prolonged QTc interval ( 500 msec) was frequently observed throughout the procedure of LT, even among patients with baseline QTc 440 msec. Therefore, it is important to optimize electrolyte balance and hemodynamic status to reduce greater risk of perioperative arrhythmias.
The investigators hypothesized that the change of QTc interval might be differ according to method of general anesthesia (inhalation agent vs. intravenous agent).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis(Who Will Undergo Planed Liver Transplantation)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Arm 1: inhalation anesthesia (desflurane) group Arm 2: total intravenous anesthesia (propofol) group
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
patients will be randomly allocated to 2 groups using computer-generated randomization method. Care provider will not be blinded to the group allocation, because anesthesiologists should be aware of the method of anesthesia.
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
inhalation anesthesia (desflurane) group
Arm Type
Experimental
Arm Description
Anesthesia is induced and maintained with desflurane and sufentanil
Arm Title
Total intravenous anesthesia (propofol) group
Arm Type
Experimental
Arm Description
Anesthesia is induced and maintained with propofol and sufentanil
Intervention Type
Drug
Intervention Name(s)
inhalation (desflurane) group
Intervention Description
Anesthesia is induced and maintained with desflurane and sufentanil
Intervention Type
Drug
Intervention Name(s)
total intravenous (propofol) anesthesia
Intervention Description
Anesthesia is induced and maintained with propofol and sufentanil
Primary Outcome Measure Information:
Title
QTc interval
Description
The investigator will assess the QTc interval 3 minutes after the reperfusion during liver transplantation.
Time Frame
3 minutes after liver reperfusion
Secondary Outcome Measure Information:
Title
QTc interval
Description
The investigator will assess the QTc interval at the end of liver transplantation.
Time Frame
at the end of the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with liver cirrhosis who will undergo planned liver transplantation
Exclusion Criteria:
1. emergent liver transplantation
2. unstable angina
3. recent MI(Myocardial Infarction)
4. uncontrolled hypertension (diastolic BP > 110mmHg)
5. implantable cardiac defibrillator
6. severe obesity (BMI>30kg/m2)
7. allergy to propofol
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
Data will become available when the script for this study is accepted in journal.
Learn more about this trial
The Comparison of Changes of QTc, Tp-e Interval, and Tp-e/QT Ratio, Tp-e/QTc Ratio on the ECG During Living Donor Liver Transplantation Under Desflurane and Total Intravenous Anesthesia -Randomized Controlled Trial
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