NCT01899248

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

May 14, 2014

Status Verified

May 1, 2014

Enrollment Period

11 months

First QC Date

July 10, 2013

Last Update Submit

May 13, 2014

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

  • proportion of patients who have more than 500 ms of QTc interval

    up to postoperative day 1 after surgery

  • Tp-e interval

    up to postoperative day 1 after surgery

Study Arms (2)

Sevoflurane

Performing liver transplantation under general anesthesia using sevoflurane

Drug: Sevoflurane

Desflurane

Performing liver transplantation under general anesthesia using desflurane

Drug: Desflurane

Interventions

SevofluraneDRUG
Sevoflurane
DesfluraneDRUG
Desflurane

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • elective liver transplantation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

SevofluraneDesflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 15, 2013

Study Start

December 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

May 14, 2014

Record last verified: 2014-05

Locations

KR(1)