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

Konkuk University Medical Center

Status: Completed

Conditions: Ischemic Heart Disease

Treatments: Drug: sevoflurane 2; Drug: propofol; Drug: sevoflurane 1; Drug: Remifentanil; Drug: sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02499445

KUH1160004

Details and patient eligibility

About

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).

Full 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).

Enrollment: 120 patients

Sex: All

Ages: 19 to 72 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Remifentanil and propofol

Active Comparator group

Description:

remifentanil (0.75 mcg/kg/min) propofol (TCI effect-site concentration 0.8-1.5 mcg/ml)

Treatment:

Drug: propofol

Drug: Remifentanil

remifentanil and sevoflurane 1

Active Comparator group

Description:

remifentanil (0.75 mcg/kg/min) sevoflurane (end-tidal 0.8 vol%)

Treatment:

Drug: Remifentanil

Drug: sevoflurane 1

sevoflurane 2 and sufentanil

Active Comparator group

Description:

sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration 0.35-0.75 ng/ml)

Treatment:

Drug: sevoflurane 2

Drug: sufentanil