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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Other: Control
* Drug: Propofol
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Patients in the control group will be receive remote ischemic preconditioning before anesthetic induction (before exposure to any anesthetic). | Other: Control<br>* Patients in the control groups do not receive any anesthetic during remote ischemic preconditioning.<br>* Other names: Not receiving any anesthetic;|
| Active Comparator: Propofol<br>Patients in the propofol groups will be receive remote ischemic preconditioning after anesthetic induction using propofol, as a main anesthetic. | Drug: Propofol<br>* Patients in the propofol group receive propofol anesthesia during remote ischemic preconditioning.<br>* Other names: Receiving propofol anesthesia;|
| Active Comparator: Sevoflurane<br>Patients in the sevoflurane groups will be receive remote ischemic preconditioning after anesthetic induction using sevoflurane, as a main anesthetic. | Drug: Sevoflurane<br>* Patients in the sevoflurane group receive sevoflurane anesthesia during remote ischemic preconditioning.<br>* Other names: Receiving sevoflurane anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size of the rat heart |  | 1 day after ischemia-reperfusion injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac troponin I after surgery |  | 72 hours postoperatively | 
| Major adverse cardiovascular and cerebrovascular events |  | Through study completion, average of 2 weeks before hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Propofol, Sevoflurane, Preconditioning