Off Pump Coronary Artery Bypass GraftNCT02222142
Volatile Versus Propofol Anesthesia in OPCAB
An observational study of Off Pump Coronary Artery Bypass Graft, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Off pump coronary artery bypass graft (OPCAB) still requires myocardial protection owing to intermittent regional ischemic episode. The investigators retrospectively evaluated the cardioprotective and clinical outcomes of propofol versus isoflurane anesthesia in patients undergoing OPCAB. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Off Pump Coronary Artery Bypass Graft
- What is being tested?
- Isoflurane
- Type of treatment
- Injection or infusion
- How many people
- 1,080 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Dec 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients underwent OPCAB from January, 2010 to December, 2012
Who may be able to join
- OPCAB
Who cannot join
- On pump conversion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Propofol and Isoflurane Anesthesia on Cardioprotection and Clinical Outcomes in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery : A Propensity-score Analysis
Off pump coronary artery bypass graft (OPCAB) still requires myocardial protection owing to intermittent regional ischemic episode. The investigators retrospectively evaluated the cardioprotective and clinical outcomes of propofol versus isoflurane anesthesia in patients undergoing OPCAB.
Read the detailed description
Several experimental and clinical researches have suggested that volatile anesthetics may reduce mortality in cardiac surgery owing to its preconditioning induced cardioprotective effect. Off-pump coronary artery bypass graft (OPCAB) surgery still requires cardioprotective strategies due to coronary hypoperfusion during anastomosis. The aim of this study was to evaluate the possible cardioprotective effect and clinical outcomes of propofol versus isoflurane anesthesia in patients undergoing OPCAB using propensity matching.
- Conditions
- Off Pump Coronary Artery Bypass Graft
- Being tested
- Isoflurane
- Keywords
- Ischemic heart disease, Off pump coronary artery bypass graft, Isoflurane, Propofol
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsofluraneDrug
Also called inhalational anesthetics
Comparison between isoflurane and propofol, Retrospective study
| Study group | Role | What they receive |
|---|---|---|
| Isoflurane group | Isoflurane inhalational anesthesia during OPCAB Receives: Drug: Isoflurane | |
| Propofol group | Total intravenous anesthesia with propofol during OPCAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
CK-MB, CRP
Comparison of CK-MB and CRP values between propofol and isoflurane groups on postoperative day, POD1 and POD 2
Measured: Change from preoperative value in CK-MR and CRP at Postoperative day(POD), POD 1 and 2
Secondary outcomes (1)
Clinical adverse outcomes
clinical adverse outcomes until postoperative 1 year
Measured: until 1 year after OPCAB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Off Pump Coronary Artery Bypass GraftStudies 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hwan Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222142
- Sponsor's protocol ID
- 2013-09-127
- Status last verified
- Aug 2014
- First submitted
- 17 Aug 2014
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Propofol and Isoflurane Anesthesia on Cardioprotection and Clinical Outcomes in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery : A Propensity-score Analysis
- ClinicalTrials.gov ID
- NCT02222142
- Acronym / sponsor ID
- 2013-09-127
- Conditions
- Off Pump Coronary Artery Bypass Graft
- Keywords
- Ischemic heart disease, Off pump coronary artery bypass graft, Isoflurane, Propofol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Aug 2014 (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.
Off pump coronary artery bypass graft (OPCAB) still requires myocardial protection owing to intermittent regional ischemic episode. The investigators retrospectively evaluated the cardioprotective and clinical outcomes of propofol versus isoflurane anesthesia in patients undergoing OPCAB.
Detailed description
Several experimental and clinical researches have suggested that volatile anesthetics may reduce mortality in cardiac surgery owing to its preconditioning induced cardioprotective effect. Off-pump coronary artery bypass graft (OPCAB) surgery still requires cardioprotective strategies due to coronary hypoperfusion during anastomosis. The aim of this study was to evaluate the possible cardioprotective effect and clinical outcomes of propofol versus isoflurane anesthesia in patients undergoing OPCAB using propensity matching.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isoflurane group | – | Drug: IsofluraneIsoflurane inhalational anesthesia during OPCAB |
| Propofol group | – | –Total intravenous anesthesia with propofol during OPCAB |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients underwent OPCAB from January, 2010 to December, 2012
Key inclusion criteria (1 listed)
- OPCAB
Key exclusion criteria (1 listed)
- On pump conversion
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 |
|---|---|---|
| IsofluraneAlso: inhalational anestheticsComparison between isoflurane and propofol, Retrospective study | Drug | Isoflurane group |
Primary outcome
CK-MB, CRP
Time frame: Change from preoperative value in CK-MR and CRP at Postoperative day(POD), POD 1 and 2
Comparison of CK-MB and CRP values between propofol and isoflurane groups on postoperative day, POD1 and POD 2
1 secondary outcome
Clinical adverse outcomes
Time frame: until 1 year after OPCAB
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 21 Aug 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 Off Pump Coronary Artery Bypass Graft, 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 1 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 21 Aug 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?
CK-MB, CRP (time frame: Change from preoperative value in CK-MR and CRP at Postoperative day(POD), POD 1 and 2). 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 21 Aug 2014; AzTrials last refreshed its copy on 27 Oct 2026.