The Effect of Inhalation Agent on the QTc Interval During Liver Transplantation: Sub Study (NCT01886664)

May 13, 2014 updated by: Seoul National University Hospital
The purpose of this study is to assess the effects of inhalation agent on corrected QT interval duration during liver transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

52

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

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

subjects who were enrolled prospectively in study (ClinicalTrials.gov Identifier NCT01886664)

Description

Inclusion Criteria:

  • elective liver transplantation

Exclusion Criteria:

  • age < 18, age > 65
  • patient refusal
  • re-transplantation

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sevoflurane
Performing liver transplantation under general anesthesia using sevoflurane
Drug: Sevoflurane
Desflurane
Performing liver transplantation under general anesthesia using desflurane
Drug: Desflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corrected QT interval (QTc interval)
Time Frame: up to postoperative day 1 after surgery
up to 10 minutes after tracheal intubation, up to 60 minutes after reperfusion, at 10 minutes after hepatectomy, at 10 minutes after biliary anastomosis, at skin closure, at the arrival on ICU, on postoperative day 1.
up to postoperative day 1 after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of patients whose QTc interval is more than 450 ms for men and 470 ms for women
Time Frame: up to postoperative day 1 after surgery
up to postoperative day 1 after surgery
proportion of patients who have more than 500 ms of QTc interval
Time Frame: up to postoperative day 1 after surgery
up to postoperative day 1 after surgery
Tp-e interval
Time Frame: up to postoperative day 1 after surgery
up to 10 minutes after tracheal intubation, up to 60 minutes after reperfusion, at 10 minutes after hepatectomy, at 10 minutes after biliary anastomosis, at skin closure, at the arrival on ICU, on postoperative day 1.
up to postoperative day 1 after surgery

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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

December 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

July 10, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (Estimate)

July 15, 2013

Study Record Updates

Last Update Posted (Estimate)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YSJeon_liver transplantation

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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