Liver TransplantationNCT01379352
Vecuronium Requirements According to the Operation Phase During Liver Transplantation Under Desflurane Anesthesia
An observational study of Liver Transplantation, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The vecuronium requirements may be reduced for recipients of living donor liver transplantation, as the vecuronium is eliminated principally by the liver. Furthermore, the requirements may be different according to the phase of surgery. Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Liver Transplantation
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Dec 2011
- 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 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective living donor liver transplantation
Who may be able to join
- patients undergoing elective living donor liver transplantation
Who cannot join
- patients who can not undergo train-of-four test due to central or peripheral neuromuscular disease.
- patients with severe cardiopulmonary diseases.
- patients who received transfusion with more than 10 units of packed red blood cells.
- primary non-functioning graft immediately after reperfusion of the graft.
- patients who administered drugs that influences the metabolism of vecuronium (such as anticonvulsant: phenytoin, carbamazepine, primidone, sodium valproate)
- patients undergoing cadaver donor liver transplantation
Trial locations and contacts
1 site in 1 country.
About this study
The vecuronium requirements may be reduced for recipients of living donor liver transplantation, as the vecuronium is eliminated principally by the liver. Furthermore, the requirements may be different according to the phase of surgery. The requirements may also be different according to the preoperative hepatic function as measured by MELD score during prehepatic phase, or graft to recipient body weight ratio (GRWR) during neohepatic phase. Therefore, the investigators are trying to investigate the difference of vecuronium requirements according to the phase of surgery or MELD score, GRWR.
Read the detailed description
The vecuronium requirements may be reduced for recipients of living donor liver transplantation, as the vecuronium is eliminated principally by the liver. Furthermore, the requirements may be different according to the phase of surgery. The requirements may by further reduced during anhepatic phase of liver transplantation. And the requirements may be increased as the graft functions during neohepatic phase.
We also postulated that the requirements may be different according to the preoperative hepatic function during preanhepatic phase, and according to the graft to recipient body weight ratio (GRWR) during neohepatic phase.
Therefore, we are trying to investigate the difference of vecuronium requirements according to the phase of surgery, MELD score, GRWR.
- Conditions
- Liver Transplantation
- Keywords
- liver transplantation, vecuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High MELD group | Preoperative MELD score greater than 20 | |
| Low MELD group | Preoperative MELD score lesser than 20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
vecuronium requirements during preanhepatic phase
total vecuronium requirements as guided by Train-of-four neuromuscular monitoring during preanhepatic phase
Measured: during prehepatic phase of liver transplantation
vecuronium requirements during anhepatic phase
total vecuronium requirements as guided by Train-of-four neuromuscular monitoring during anhepatic phase
Measured: during anhepatic phase of liver transplantation
vecuronium requirements during neohepatic phase
total vecuronium requirements as guided by Train-of-four neuromuscular monitoring during neohepatic phase
Measured: during neohepatic phase of liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaab Soo Kim, Samsung Medical Center
- Investigators
- Gaab Soo Kim, M.D.,Ph.D., Study director, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379352
- Sponsor's protocol ID
- 2011-04-015
- Status last verified
- Dec 2013
- First submitted
- 21 Jun 2011
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vecuronium Requirements According to the Operation Phase During Liver Transplantation Under Desflurane Anesthesia
- ClinicalTrials.gov ID
- NCT01379352
- Acronym / sponsor ID
- 2011-04-015
- Conditions
- Liver Transplantation
- Keywords
- liver transplantation, vecuronium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Jun 2011 (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 vecuronium requirements may be reduced for recipients of living donor liver transplantation, as the vecuronium is eliminated principally by the liver. Furthermore, the requirements may be different according to the phase of surgery. The requirements may also be different according to the preoperative hepatic function as measured by MELD score during prehepatic phase, or graft to recipient body weight ratio (GRWR) during neohepatic phase. Therefore, the investigators are trying to investigate the difference of vecuronium requirements according to the phase of surgery or MELD score, GRWR.
Detailed description
The vecuronium requirements may be reduced for recipients of living donor liver transplantation, as the vecuronium is eliminated principally by the liver. Furthermore, the requirements may be different according to the phase of surgery. The requirements may by further reduced during anhepatic phase of liver transplantation. And the requirements may be increased as the graft functions during neohepatic phase.
We also postulated that the requirements may be different according to the preoperative hepatic function during preanhepatic phase, and according to the graft to recipient body weight ratio (GRWR) during neohepatic phase.
Therefore, we are trying to investigate the difference of vecuronium requirements according to the phase of surgery, MELD score, GRWR.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High MELD group | – | –Preoperative MELD score greater than 20 |
| Low MELD group | – | –Preoperative MELD score lesser than 20 |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective living donor liver transplantation
Key inclusion criteria (1 listed)
- patients undergoing elective living donor liver transplantation
Key exclusion criteria (6 listed)
- patients who can not undergo train-of-four test due to central or peripheral neuromuscular disease.
- patients with severe cardiopulmonary diseases.
- patients who received transfusion with more than 10 units of packed red blood cells.
- primary non-functioning graft immediately after reperfusion of the graft.
- patients who administered drugs that influences the metabolism of vecuronium (such as anticonvulsant: phenytoin, carbamazepine, primidone, sodium valproate)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
vecuronium requirements during preanhepatic phase
Time frame: during prehepatic phase of liver transplantation
total vecuronium requirements as guided by Train-of-four neuromuscular monitoring during preanhepatic phase
vecuronium requirements during anhepatic phase
Time frame: during anhepatic phase of liver transplantation
total vecuronium requirements as guided by Train-of-four neuromuscular monitoring during anhepatic phase
vecuronium requirements during neohepatic phase
Time frame: during neohepatic phase of liver transplantation
total vecuronium requirements as guided by Train-of-four neuromuscular monitoring during neohepatic phase
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 25 Dec 2013.
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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.
Gaab Soo Kim, M.D.,Ph.D. study director
Samsung Medical Center
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 Liver Transplantation, run by Samsung Medical Center 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 6 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 25 Dec 2013. 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?
vecuronium requirements during preanhepatic phase (time frame: during prehepatic phase of liver transplantation). The study lists 3 primary outcomes in all. 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 25 Dec 2013.