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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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ClinicalTrials.gov Identifier: NCT03864276
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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).


Condition or disease Intervention/treatment Phase
Liver Cirrhosis(Who Will Undergo Planed Liver Transplantation) Drug: inhalation (desflurane) group Drug: total intravenous (propofol) anesthesia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Arm 1: inhalation anesthesia (desflurane) group Arm 2: total intravenous anesthesia (propofol) group
Masking: Triple (Participant, Investigator, Outcomes 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.
Primary Purpose: Other
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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: inhalation anesthesia (desflurane) group
Anesthesia is induced and maintained with desflurane and sufentanil
Drug: inhalation (desflurane) group
Anesthesia is induced and maintained with desflurane and sufentanil

Experimental: Total intravenous anesthesia (propofol) group
Anesthesia is induced and maintained with propofol and sufentanil
Drug: total intravenous (propofol) anesthesia
Anesthesia is induced and maintained with propofol and sufentanil




Primary Outcome Measures :
  1. QTc interval [ Time Frame: 3 minutes after liver reperfusion ]
    The investigator will assess the QTc interval 3 minutes after the reperfusion during liver transplantation.


Secondary Outcome Measures :
  1. QTc interval [ Time Frame: at the end of the surgery ]
    The investigator will assess the QTc interval at the end of liver transplantation.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864276


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Bon-Nyeo Koo, Ph.D.    82-2-2228-2420    koobn@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03864276     History of Changes
Other Study ID Numbers: 4-2018-1164
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will become available when the script for this study is accepted in journal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Anesthetics
Propofol
Sufentanil
Desflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Inhalation