Anesthesia, GeneralNCT01899248
The Effect of Inhalation Agent on the QTc Interval During Liver Transplantation: Sub Study (NCT01886664)
An observational study of Anesthesia, General, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to assess the effects of inhalation agent on corrected QT interval duration during liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Sevoflurane and Desflurane
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects who were enrolled prospectively in study (ClinicalTrials.gov Identifier NCT01886664)
Who may be able to join
- elective liver transplantation
Who cannot join
- age < 18, age > 65
- patient refusal
- re-transplantation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the effects of inhalation agent on corrected QT interval duration during liver transplantation.
- Conditions
- Anesthesia, General
- Being tested
- Sevoflurane, Desflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
DesfluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Performing liver transplantation under general anesthesia using sevoflurane Receives: Drug: Sevoflurane | |
| Desflurane | Performing liver transplantation under general anesthesia using desflurane Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: up to postoperative day 1 after surgery
proportion of patients who have more than 500 ms of QTc interval
Measured: up to postoperative day 1 after surgery
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.
Measured: up to postoperative day 1 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startDec 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899248
- Sponsor's protocol ID
- YSJeon_liver transplantation
- Status last verified
- May 2014
- First submitted
- 10 Jul 2013
- Last updated
- 14 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inhalation Agent on the QTc Interval During Liver Transplantation: Sub Study (NCT01886664)
- ClinicalTrials.gov ID
- NCT01899248
- Acronym / sponsor ID
- YSJeon_liver transplantation
- Conditions
- Anesthesia, General
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 15 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effects of inhalation agent on corrected QT interval duration during liver transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | – | Drug: SevofluranePerforming liver transplantation under general anesthesia using sevoflurane |
| Desflurane | – | Drug: DesfluranePerforming liver transplantation under general anesthesia using desflurane |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects who were enrolled prospectively in study (ClinicalTrials.gov Identifier NCT01886664)
Key inclusion criteria (1 listed)
- elective liver transplantation
Key exclusion criteria (3 listed)
- age < 18, age > 65
- patient refusal
- re-transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevoflurane | Drug | Sevoflurane |
| Desflurane | Drug | Desflurane |
Primary outcome
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.
3 secondary outcomes
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
proportion of patients who have more than 500 ms of QTc interval
Time frame: up to postoperative day 1 after surgery
Tp-e interval
Time frame: up to postoperative day 1 after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, General, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corrected QT interval (QTc interval) (time frame: up to postoperative day 1 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.