Ischemic Heart DiseaseNCT02499445
Myocardial Injury in Remifentanil-based Versus Sevoflurane-sufentanil Balanced Regimens in OPCAB Surgery
A study testing Remifentanil, sevoflurane 1 and sevoflurane 2 in people with Ischemic Heart Disease, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
In patients undergoing off-pump coronary artery bypass (OPCAB) surgery with different anesthesia regimens: remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site concentration 0.8-1.5 mcg/ml) (Group -RP); remifentanil (0.75 mcg/kg/min) and sevoflurane (end-tidal 0.8 vol%) (Group-RS), or sevoflurane (end-tidal… Read more about this study
- Who is it for?
- Ages 19 to 72 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Remifentanil, sevoflurane 1 and sevoflurane 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2007to Nov 2014
- 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 19 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient undergoing OPCAB surgery
- patient signed written informed consent
Who cannot join
- patient with Intra-aortic balloon pump
- patient with renal replacement therapy
- patient wants to withdraw the participation to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparisons of Myocardial Injury After Using Different Anesthetics Regimens for Off-pump Coronary Artery Bypass Surgery: Remifentanil-based Versus Sevoflurane-sufentanil Balanced Regimen
In patients undergoing off-pump coronary artery bypass (OPCAB) surgery with different anesthesia regimens: remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site concentration 0.8-1.5 mcg/ml) (Group -RP); remifentanil (0.75 mcg/kg/min) and sevoflurane (end-tidal 0.8 vol%) (Group-RS), or sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration 0.35-0.75 ng/ml) (Group-SS), intergroup difference in the level of Troponin I (c-TnI) and creatinine kinase subtype-MB is determined before surgery (control), during vascular graft harvesting (harvesting), after completing graft construction (postgrafting), and one day after surgery (postoperative).
Read the detailed description
To determine the difference of myocardial injury upon using different anesthesia regimens: remifentanil-based regimen versus sevoflurane-sufentanil balanced regimen.
Patients undergoing off-pump coronary artery bypass (OPCAB) surgery are randomly allocated to get remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site concentration 0.8-1.5 mcg/ml) (Group -RP), remifentanil (0.75 mcg/kg/min) and sevoflurane (end-tidal 0.8 vol%) (Group-RS), or sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration0.35-0.75 ng/ml) (Group-SS).
Intergroup difference in the level of Troponin I (c-TnI) and creatine kinase-MB is determined before surgery (control), during vascular graft harvesting (harvesting), after completing graft construction (postgrafting), 1 day after surgery (postoperative).
- Conditions
- Ischemic Heart Disease
- Being tested
- Remifentanil, sevoflurane 1, sevoflurane 2, propofol, sufentanil
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
administering remifentanil for anesthesia maintenance
sevoflurane 1Drug
administering sevoflurane 1 for anesthesia maintenance
sevoflurane 2Drug
administering sevoflurane 2 for anesthesia maintenance
propofolDrug
administering propofol for anesthesia maintenance
sufentanilDrug
administering sufentanil for anesthesia maintenance
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil and propofol | Active comparator | remifentanil (0.75 mcg/kg/min) propofol (TCI effect-site concentration 0.8-1.5 mcg/ml) Receives: Drug: Remifentanil; Drug: propofol |
| remifentanil and sevoflurane 1 | Active comparator | remifentanil (0.75 mcg/kg/min) sevoflurane (end-tidal 0.8 vol%) Receives: Drug: Remifentanil; Drug: sevoflurane 1 |
| sevoflurane 2 and sufentanil | Active comparator | sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration 0.35-0.75 ng/ml) Receives: Drug: sevoflurane 2; Drug: sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
troponin I
troponin I for myocardial injury
Measured: one day after surgery
Secondary outcomes (1)
creatinin kinase-MB
creatinine kinase-MB
Measured: one day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startNov 2007
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499445
- Sponsor's protocol ID
- KUH1160004
- Status last verified
- Jul 2015
- First submitted
- 5 Mar 2015
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Myocardial Injury After Using Different Anesthetics Regimens for Off-pump Coronary Artery Bypass Surgery: Remifentanil-based Versus Sevoflurane-sufentanil Balanced Regimen
- ClinicalTrials.gov ID
- NCT02499445
- Acronym / sponsor ID
- KUH1160004
- Conditions
- Ischemic Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 16 Jul 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.
In patients undergoing off-pump coronary artery bypass (OPCAB) surgery with different anesthesia regimens: remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site concentration 0.8-1.5 mcg/ml) (Group -RP); remifentanil (0.75 mcg/kg/min) and sevoflurane (end-tidal 0.8 vol%) (Group-RS), or sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration 0.35-0.75 ng/ml) (Group-SS), intergroup difference in the level of Troponin I (c-TnI) and creatinine kinase subtype-MB is determined before surgery (control), during vascular graft harvesting (harvesting), after completing graft construction (postgrafting), and one day after surgery (postoperative).
Detailed description
To determine the difference of myocardial injury upon using different anesthesia regimens: remifentanil-based regimen versus sevoflurane-sufentanil balanced regimen.
Patients undergoing off-pump coronary artery bypass (OPCAB) surgery are randomly allocated to get remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site concentration 0.8-1.5 mcg/ml) (Group -RP), remifentanil (0.75 mcg/kg/min) and sevoflurane (end-tidal 0.8 vol%) (Group-RS), or sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration0.35-0.75 ng/ml) (Group-SS).
Intergroup difference in the level of Troponin I (c-TnI) and creatine kinase-MB is determined before surgery (control), during vascular graft harvesting (harvesting), after completing graft construction (postgrafting), 1 day after surgery (postoperative).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remifentanil and propofol | Active comparator | Drug: Remifentanil, Drug: propofolremifentanil (0.75 mcg/kg/min) propofol (TCI effect-site concentration 0.8-1.5 mcg/ml) |
| remifentanil and sevoflurane 1 | Active comparator | Drug: Remifentanil, Drug: sevoflurane 1remifentanil (0.75 mcg/kg/min) sevoflurane (end-tidal 0.8 vol%) |
| sevoflurane 2 and sufentanil | Active comparator | Drug: sevoflurane 2, Drug: sufentanilsevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration 0.35-0.75 ng/ml) |
Who may qualify
- Ages
- 19 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient undergoing OPCAB surgery
- patient signed written informed consent
Key exclusion criteria (3 listed)
- patient with Intra-aortic balloon pump
- patient with renal replacement therapy
- patient wants to withdraw the participation to the study
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 |
|---|---|---|
| Remifentaniladministering remifentanil for anesthesia maintenance | Drug | Remifentanil and propofol, remifentanil and sevoflurane 1 |
| sevoflurane 1administering sevoflurane 1 for anesthesia maintenance | Drug | remifentanil and sevoflurane 1 |
| sevoflurane 2administering sevoflurane 2 for anesthesia maintenance | Drug | sevoflurane 2 and sufentanil |
| propofoladministering propofol for anesthesia maintenance | Drug | Remifentanil and propofol |
| sufentaniladministering sufentanil for anesthesia maintenance | Drug | sevoflurane 2 and sufentanil |
Primary outcome
troponin I
Time frame: one day after surgery
troponin I for myocardial injury
1 secondary outcome
creatinin kinase-MB
Time frame: one day 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 16 Jul 2015.
Related trials for Ischemic Heart Disease
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Active, not recruiting
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Coronary Microvascular Disease, Ischemic Heart Disease
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Recruiting
Use of GeriKit to Better Phenotype Older Adults With Ischemic Heart Disease
Ischemic Heart Disease
Active, not recruiting
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
Coronary Artery Disease, Atherosclerosis of Coronary Artery
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 Remifentanil, sevoflurane 1 and sevoflurane 2 in people with Ischemic Heart Disease, run by Konkuk University 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 2 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 16 Jul 2015. 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?
troponin I (time frame: one day 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 16 Jul 2015; AzTrials last refreshed its copy on 8 Nov 2026.