Effect of Propofol on Cardioprotective Role of Remote Ischemic Preconditioning (RIPC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Infarct size of the rat heart
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA class I~III patients undergoing cardiac surgery using cardiopulmonary bypass
排除标准
- •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
研究组 & 干预措施
Control
Patients in the control group will be receive remote ischemic preconditioning before anesthetic induction (before exposure to any anesthetic).
干预措施: Control (Other)
Propofol
Patients in the propofol groups will be receive remote ischemic preconditioning after anesthetic induction using propofol, as a main anesthetic.
干预措施: Propofol (Drug)
Sevoflurane
Patients in the sevoflurane groups will be receive remote ischemic preconditioning after anesthetic induction using sevoflurane, as a main anesthetic.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Infarct size of the rat heart
时间窗: 1 day after ischemia-reperfusion injury
次要结局
- Cardiac troponin I after surgery(72 hours postoperatively)
- Major adverse cardiovascular and cerebrovascular events(Through study completion, average of 2 weeks before hospital discharge)
研究者
Yunseok Jeon
Principal Investigator
Seoul National University Hospital