Effect of Propofol on Cardioprotective Role of Remote Ischemic Preconditioning (RIPC)

Seoul National University

Status: Completed

Conditions: Myocardial Infarction

Treatments: Drug: Sevoflurane; Drug: Propofol; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02932722

RIPC_propofol

1605-079-761 (Other Identifier)

Details and patient eligibility

About

This study involves research using human subjects (cardiac surgical patients) to evaluate the effect of remote ischemic preconditioning (RIPC) on cardioprotective outcomes. RIPC applied to upper or lower extremities has been shown cardioprotective role by lowering release of cardiac troponin in patients with cardiac diseases. However, it is not clear whether anesthetics, such as propofol or sevoflurane, may impair the cardioprotective effect of RIPC in cardiac surgical patients. Therefore, the purpose of the study is to compare the effects of anesthetics on cardioprotection of RIPC in patients undergoing cardiac surgery.

Full description

Patients undergoing cardiac surgery using cardiopulmonary bypass will be randomized to control, propofol, or sevoflurane group. Patients in the control group will receive remote ischemic preconditioning (RIPC) on their upper arms before anesthetic induction. Patients in the propofol or sevoflurane groups will receive RIPC after anesthetic induction using propofol or sevoflurane, respectively. In all patients, arterial blood samples will be obtained before and after each RIPC. From the samples, human dialysate will be obtained and perfused to rat heart through Langendorff apparatus before ischemia-reperfusion injury to the rat heart. Infarct size of the sectioned rat heart will be compared among the three - control, propofol, and sevoflurane - groups.

Enrollment: 51 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA class I~III patients undergoing cardiac surgery using cardiopulmonary bypass

Exclusion criteria

• Cardiac surgery without using cardiopulmonary bypass
• Descending thoracic aortic surgery
• Strenuous exercise, excessive alcohol or caffeine intake 24 hours before remote ischemic preconditioning
• Left ventricular ejection fraction < 30%
• Uncontrolled hypertension or diabetes mellitus
• Severe renal or hepatic dysfunction
• Patients on hemodialysis
• Patients with arterio-venous fistula on arms or any reason to protect arms
• Peripheral vascular or nerve disease, bleeding tendency
• Preoperative use of IABP, ECMO, or ventricular assist devices
• Emergency operation, redo operation
• Refuse to enroll
• Pregnancy
• Preoperative use of beta-blockers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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51 participants in 3 patient groups

Control

Sham Comparator group

Description:

Patients in the control group will be receive remote ischemic preconditioning before anesthetic induction (before exposure to any anesthetic).

Treatment:

Other: Control

Propofol

Active Comparator group

Description:

Patients in the propofol groups will be receive remote ischemic preconditioning after anesthetic induction using propofol, as a main anesthetic.

Treatment:

Drug: Propofol

Sevoflurane

Active Comparator group

Description:

Patients in the sevoflurane groups will be receive remote ischemic preconditioning after anesthetic induction using sevoflurane, as a main anesthetic.

Treatment:

Drug: Sevoflurane