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

Anesthesia, General Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899248
• Other study ID #: YSJeon_liver transplantation
• Status: Completed
• Phase: N/A
• First received: July 10, 2013
• Last updated: May 13, 2014
• Start date: December 2012
• Est. completion date: November 2013

Study information

• Verified date: May 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the effects of inhalation agent on corrected QT interval duration during liver transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• elective liver transplantation

Exclusion Criteria:

• age < 18, age > 65

• patient refusal

• re-transplantation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Drug:
• Sevoflurane

• Desflurane

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	corrected QT interval (QTc interval)	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	Yes
Secondary	proportion of patients whose QTc interval is more than 450 ms for men and 470 ms for women		up to postoperative day 1 after surgery	Yes
Secondary	proportion of patients who have more than 500 ms of QTc interval		up to postoperative day 1 after surgery	Yes
Secondary	Tp-e interval	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	Yes