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

Liver Cirrhosis(Who Will Undergo Planed Liver Transplantation) Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864276
• Other study ID #: 4-2018-1164
• Status: Completed
• Phase: N/A
• Start date: February 17, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2021
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Cirrhosis(Who Will Undergo Planed Liver Transplantation)

Intervention

Drug:
• inhalation (desflurane) group
Anesthesia is induced and maintained with desflurane and sufentanil
• total intravenous (propofol) anesthesia
Anesthesia is induced and maintained with propofol and sufentanil

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QTc interval	The investigator will assess the QTc interval 3 minutes after the reperfusion during liver transplantation.	3 minutes after liver reperfusion
Secondary	QTc interval	The investigator will assess the QTc interval at the end of liver transplantation.	at the end of the surgery