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

Not Applicable

Completed

• Conditions: Myocardial Infarction
• Interventions: Other: Control; Drug: Propofol; Drug: Sevoflurane

• Registration Number: NCT02932722
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-10-12
• Study First Posted: 2016-10-13
• Study Start: 2017-02-22
• Status Verified: 2018-02
• Primary Completion: 2018-02-07
• Study Completion: 2018-02-07
• Last Update Submitted: 2018-02-19
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Patients in the control group will be receive remote ischemic preconditioning before anesthetic induction (before exposure to any anesthetic).
Propofol	Propofol	Patients in the propofol groups will be receive remote ischemic preconditioning after anesthetic induction using propofol, as a main anesthetic.
Sevoflurane	Sevoflurane	Patients in the sevoflurane groups will be receive remote ischemic preconditioning after anesthetic induction using sevoflurane, as a main anesthetic.

Primary Outcome Measures

Name	Time	Method
Infarct size of the rat heart	1 day after ischemia-reperfusion injury

Secondary Outcome Measures

Name	Time	Method
Cardiac troponin I after surgery	72 hours postoperatively
Major adverse cardiovascular and cerebrovascular events	Through study completion, average of 2 weeks before hospital discharge

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of