Anesthetics, IntravenousPhase 4NCT02566733
Minto Model in Effect Site Mode for Target-Controlled Infusion of Remifentanil During Cardiopulmonary Bypass
A Phase 4 study testing Remiva and Ultiva in people with Anesthetics, Intravenous and Pharmacology, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Target controlled infusion with remifentanil is widely used during cardiac surgery, wich is performed using the Minto model. It was derived from patients undergoing general surgery. However, pharmacokinetics of remifentanil can be changed during cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Anesthetics, Intravenous, Pharmacology, Anesthetics
- What is being tested?
- Remiva and Ultiva
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Jun 2016
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with the ASA class I~III undergoing elective cardiac surgery using cardiopulmonary bypass
Who cannot join
- Patients not using target controlled infusion during the operation
- Patients with drug/substance abuse
- Patients using analgesics before this study starts
- Pregnant women
- Patients who rejected study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance of the Minto Model in Effect Site Mode for Target Controlled Infusion of Remifentanil During Cardiopulmonary Bypass
Target controlled infusion with remifentanil is widely used during cardiac surgery, wich is performed using the Minto model. It was derived from patients undergoing general surgery. However, pharmacokinetics of remifentanil can be changed during cardiopulmonary bypass. The investigators tested whether Minto model for target controlled infusion produces constant plasma remifentanil concentration during the cardiac surgery.
- Being tested
- Remiva, Ultiva
- Keywords
- remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemivaDrug
Also called generic drug of remifentanil, Remiva™
Target controlled infusion of remifentanil (generic drug, Remiva™)
UltivaDrug
Also called brand-named drug of remifentanil, Ultiva™
Target controlled infusion of remifentanil (brand-named drug, Ultiva™)
| Study group | Role | What they receive |
|---|---|---|
| Remiva | Experimental | This experimental group will use a generic drug of remifentanil, Remiva™ from Hana Pharmaceutical company. Receives: Drug: Remiva |
| Ultiva | Active comparator | This arm group will use a brand-named drug of remifentanil, Ultiva™ from GlaxoSmithKline company. Receives: Drug: Ultiva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median prediction error
Measured: during CPB
Secondary outcomes (2)
changes of measured total remifentanil concentration
Measured: 1 hour after anesthesia induction, 30/60/90 min after the beginning of cardiopulmonary bypass, 1 hour after the end of cardiopulmonary bypass
Median absolute prediction error
Measured: during CPB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthetics, IntravenousStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Kyong Kim, Seoul National University Hospital
- Investigators
- Tae Kyong Kim, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566733
- Sponsor's protocol ID
- Remifentanil_CPB
- Status last verified
- Oct 2016
- First submitted
- 29 Sep 2015
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the Minto Model in Effect Site Mode for Target Controlled Infusion of Remifentanil During Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT02566733
- Acronym / sponsor ID
- Remifentanil_CPB
- Keywords
- remifentanil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Oct 2015 (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.
Target controlled infusion with remifentanil is widely used during cardiac surgery, wich is performed using the Minto model. It was derived from patients undergoing general surgery. However, pharmacokinetics of remifentanil can be changed during cardiopulmonary bypass. The investigators tested whether Minto model for target controlled infusion produces constant plasma remifentanil concentration during the cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remiva | Experimental | Drug: RemivaThis experimental group will use a generic drug of remifentanil, Remiva™ from Hana Pharmaceutical company. |
| Ultiva | Active comparator | Drug: UltivaThis arm group will use a brand-named drug of remifentanil, Ultiva™ from GlaxoSmithKline company. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with the ASA class I~III undergoing elective cardiac surgery using cardiopulmonary bypass
Key exclusion criteria (5 listed)
- Patients not using target controlled infusion during the operation
- Patients with drug/substance abuse
- Patients using analgesics before this study starts
- Pregnant women
- Patients who rejected study participation
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 |
|---|---|---|
| RemivaAlso: generic drug of remifentanil, Remiva™Target controlled infusion of remifentanil (generic drug, Remiva™) | Drug | Remiva |
| UltivaAlso: brand-named drug of remifentanil, Ultiva™Target controlled infusion of remifentanil (brand-named drug, Ultiva™) | Drug | Ultiva |
Primary outcome
Median prediction error
Time frame: during CPB
2 secondary outcomes
changes of measured total remifentanil concentration
Time frame: 1 hour after anesthesia induction, 30/60/90 min after the beginning of cardiopulmonary bypass, 1 hour after the end of cardiopulmonary bypass
Median absolute prediction error
Time frame: during CPB
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 19 Oct 2016.
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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.
Tae Kyong Kim, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remiva and Ultiva in people with Anesthetics, Intravenous and Pharmacology, 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 5 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 19 Oct 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Median prediction error (time frame: during CPB). 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 19 Oct 2016.