Ischemic heart disease
Conditions
Interventions
Remifentanil group: to receive remifentanil infusion at a rate of 0.5mcg/kg/min (0.3ml/kg/h) for 30 minutes between induction of general anesthesia and sternotomy.
Placebo group: to receive 0.9% sal
Sponsors
The University of Tokyo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with acute coronary syndrome scheduled for elective OPCAB with multiple distal anastomoses (>= 3) via a median sternotomy approach 2. 20 years or older at the time of obtaining informed consent 3. Patients with written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with unstable angina 2. Patients with history of acute myocardial infarction within 4 weeks prior to surgery 3. Patients with low cardiac output (EF < 30%, inotropic or mechanical circulatory support before surgery) 4. Patients who had prior CABG 5. Patients who had percutaneous coronary intervention within 6 weeks prior to surgery 6. Patients scheduled for combined surgery involving a second organ 7. Patients with opioid use 8. Patients with corticosteroid use 9. Patients with insulin or sulfonylurea use 10. Patients with an active concomitant infection 11. Patients with chronic inflammation (autoimmune disease or malignancy) 12. Patients who have received remifentanil within 3 months prior to surgery 13. Patients with BMI >= 30 14. Patients with atrial fibrillation, second- or third- degree atrioventricular block, or left bundle branch block 15. Patients with moderate or severe aortic or mitral valve disease 16. Patients with severe renal disease (eGFR < 30ml/min/1.73m2) 17. Patients with severe hepatic dysfunction (AST or ALT >= 100IU/l) 18. Patients with severe pulmonary disease (intestinal pneumonia, COPD, or asthma treated with medication) 19. Female patients who are pregnant or possibly pregnant 20. Female patients who are breastfeeding 21. Patients who have received any investigational drug within 3 months before initiation of this trial 22. Patients whom principal investigator or co-investigator judges to be inappropriate as a participant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in cardiac troponin I levels between before the first anastomosis and 12h after the last one | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in cardiac markers (cTnI, CK-MB, and h-FABP) 2. Intraoperative complications 3. Postoperative complications 4. Postoperative recovery 5. Changes in HMGB-1 6. Changes in inflammatory and anti-inflammatory cytokines (IL-6, IL-8, TNF-alpha, GM-CSF, and IL-10) 7. Changes in peripheral blood leukocyte mRNA expression 8. Changes in total and differential leukocyte count 9. Changes in stress hormones (cortisol and ACTH) 10. Changes in CRP 11. Perioperative vital signs 12. Perioperative cardiac function | — |
Countries
Japan
Contacts
Public ContactYousuke Imai
The University of Tokyo Hospital The Anesthesiology and Pain Relief Center
Outcome results
None listed