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

October 14, 2021 updated by: Yonsei University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QTc interval
Time Frame: 3 minutes after liver reperfusion
The investigator will assess the QTc interval 3 minutes after the reperfusion during liver transplantation.
3 minutes after liver reperfusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QTc interval
Time Frame: at the end of the surgery
The investigator will assess the QTc interval at the end of liver transplantation.
at the end of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 4, 2019

First Posted (Actual)

March 6, 2019

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2018-1164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

Data will become available when the script for this study is accepted in journal.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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