Myocardial Injury in Remifentanil-based Versus Sevoflurane-sufentanil Balanced Regimens in OPCAB Surgery

Study Overview
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Brief Summary
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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
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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).

Official Title
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Comparisons of Myocardial Injury After Using Different Anesthetics Regimens for Off-pump Coronary Artery Bypass Surgery: Remifentanil-based Versus Sevoflurane-sufentanil Balanced Regimen

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Drug: Remifentanil
* Drug: sevoflurane 1
* Drug: sevoflurane 2
* Drug: propofol
* Drug: sufentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient undergoing OPCAB surgery patient signed written informed consent Exclusion Criteria: patient with Intra-aortic balloon pump patient with renal replacement therapy patient wants to withdraw the participation to the study

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remifentanil and propofol<br>remifentanil (0.75 mcg/kg/min) propofol (TCI effect-site concentration 0.8-1.5 mcg/ml) | Drug: Remifentanil<br>* administering remifentanil for anesthesia maintenance<br>Drug: propofol<br>* administering propofol for anesthesia maintenance<br>|
| Active Comparator: remifentanil and sevoflurane 1<br>remifentanil (0.75 mcg/kg/min) sevoflurane (end-tidal 0.8 vol%) | Drug: Remifentanil<br>* administering remifentanil for anesthesia maintenance<br>Drug: sevoflurane 1<br>* administering sevoflurane 1 for anesthesia maintenance<br>|
| Active Comparator: sevoflurane 2 and sufentanil<br>sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration 0.35-0.75 ng/ml) | Drug: sevoflurane 2<br>* administering sevoflurane 2 for anesthesia maintenance<br>Drug: sufentanil<br>* administering sufentanil for anesthesia maintenance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| troponin I | troponin I for myocardial injury | one day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| creatinin kinase-MB | creatinine kinase-MB | one day after surgery |