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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

NCT ID: NCT03864276

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-17

Study Completion Date

2020-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Liver Cirrhosis(Who Will Undergo Planed Liver Transplantation)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Arm 1: inhalation anesthesia (desflurane) group Arm 2: total intravenous anesthesia (propofol) group
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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inhalation anesthesia (desflurane) group

Anesthesia is induced and maintained with desflurane and sufentanil

Group Type EXPERIMENTAL

inhalation (desflurane) group

Intervention Type DRUG

Anesthesia is induced and maintained with desflurane and sufentanil

Total intravenous anesthesia (propofol) group

Anesthesia is induced and maintained with propofol and sufentanil

Group Type EXPERIMENTAL

total intravenous (propofol) anesthesia

Intervention Type DRUG

Anesthesia is induced and maintained with propofol and sufentanil

Interventions

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inhalation (desflurane) group

Anesthesia is induced and maintained with desflurane and sufentanil

Intervention Type DRUG

total intravenous (propofol) anesthesia

Anesthesia is induced and maintained with propofol and sufentanil

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2018-1164

Identifier Type: -

Identifier Source: org_study_id