Liver Cirrhosis(Who Will Undergo Planed Liver Transplantation)NCT03864276
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
A study testing inhalation (desflurane) group and total intravenous (propofol) anesthesia in people with Liver Cirrhosis(Who Will Undergo Planed Liver Transplantation), run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Cirrhosis(Who Will Undergo Planed Liver Transplantation)
- What is being tested?
- inhalation (desflurane) group and total intravenous (propofol) anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Feb 2019to 31 Dec 2020
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with liver cirrhosis who will undergo planned liver transplantation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
About this study
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).
- Being tested
- inhalation (desflurane) group, total intravenous (propofol) anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhalation (desflurane) groupDrug
Anesthesia is induced and maintained with desflurane and sufentanil
total intravenous (propofol) anesthesiaDrug
Anesthesia is induced and maintained with propofol and sufentanil
| Study group | Role | What they receive |
|---|---|---|
| inhalation anesthesia (desflurane) group | Experimental | Anesthesia is induced and maintained with desflurane and sufentanil Receives: Drug: inhalation (desflurane) group |
| Total intravenous anesthesia (propofol) group | Experimental | Anesthesia is induced and maintained with propofol and sufentanil Receives: Drug: total intravenous (propofol) anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc interval
The investigator will assess the QTc interval 3 minutes after the reperfusion during liver transplantation.
Measured: 3 minutes after liver reperfusion
Secondary outcomes (1)
QTc interval
The investigator will assess the QTc interval at the end of liver transplantation.
Measured: at the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start17 Feb 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cirrhosis(Who Will Undergo Planed Liver Transplantation)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: inhalation anesthesia (desflurane) group Arm 2: total intravenous anesthesia (propofol) group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864276
- Sponsor's protocol ID
- 4-2018-1164
- Status last verified
- Oct 2021
- First submitted
- 4 Mar 2019
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03864276
- Acronym / sponsor ID
- 4-2018-1164
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 17 Feb 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 Mar 2019 (actual)
- 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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Arm 1: inhalation anesthesia (desflurane) group Arm 2: total intravenous anesthesia (propofol) group
| Arm | Type | Receives |
|---|---|---|
| inhalation anesthesia (desflurane) group | Experimental | Drug: inhalation (desflurane) groupAnesthesia is induced and maintained with desflurane and sufentanil |
| Total intravenous anesthesia (propofol) group | Experimental | Drug: total intravenous (propofol) anesthesiaAnesthesia is induced and maintained with propofol and sufentanil |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with liver cirrhosis who will undergo planned liver transplantation
Key exclusion criteria (7 listed)
- 1. emergent liver transplantation
- 2. unstable angina
- 3. recent MI(Myocardial Infarction)
- 4. uncontrolled hypertension (diastolic BP > 110mmHg)
- 5. implantable cardiac defibrillator
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 |
|---|---|---|
| inhalation (desflurane) groupAnesthesia is induced and maintained with desflurane and sufentanil | Drug | inhalation anesthesia (desflurane) group |
| total intravenous (propofol) anesthesiaAnesthesia is induced and maintained with propofol and sufentanil | Drug | Total intravenous anesthesia (propofol) group |
Primary outcome
QTc interval
Time frame: 3 minutes after liver reperfusion
The investigator will assess the QTc interval 3 minutes after the reperfusion during liver transplantation.
1 secondary outcome
QTc interval
Time frame: at the end of the 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 15 Oct 2021.
- Individual participant dataSharing planned: Yes
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?
A study testing inhalation (desflurane) group and total intravenous (propofol) anesthesia in people with Liver Cirrhosis(Who Will Undergo Planed Liver Transplantation), run by Yonsei University 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 7 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 15 Oct 2021. 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?
QTc interval (time frame: 3 minutes after liver reperfusion). 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 15 Oct 2021.