NCT00971607已完成2 期
Sevoflurane Sedation During Primary Percutaneous Coronary Intervention.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Infarct size by area under the curve of cardiac markers.
研究概览
简要总结
Ischemic postconditioning can reduce myocardial injury following myocardial infarction.
A potential pharmacological agent is the anesthetic Sevoflurane. The investigators' hypothesis is that sevoflurane during primary percutaneous coronary intervention (PCI) will reduce infarct size.
详细描述
Patients with first STEMI that will be treated by primary PCI, will be randomized to sedation with Sevoflurane during the procedure or to usual care.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First STEMI, presenting within 6 hours after the onset of chest pain
- •Symptoms lasting > 30 minutes
- •Persistent ST-segment elevation > 0.1 mV in 2 or more contiguous leads
排除标准
- •Hypersensitivity to sevoflurane or other halogenated agents
- •Malignant hyperthermia
- •Cardiac arrest
- •Cardiogenic shock
- •Previous myocardial infarction or coronary bypass surgery
- •Pre-infarction angina
- •Heart failure (NYHA III/IV)
- •Chronic inflammatory disease
- •Severe renal impairment
- •Hepatic dysfunction
- •Use of Glyburide
研究组 & 干预措施
1
Active Comparator
Sevoflurane
干预措施: Oxygen + Sevoflurane (Drug)
2
Placebo Comparator
Oxygen
干预措施: Oxygen (placebo) (Drug)
结局指标
主要结局
Infarct size by area under the curve of cardiac markers.
时间窗: 3 days
次要结局
- Left ventricular function.(Six month)
- ST segment elevation resolution(90 minutes)
- TIMI flow(60 minutes)
- CRP(24 hours)
- Renal function(48 hours)
- Patient satisfaction(1 hour)
研究者
Shahar Lavi
Principal Investigator
Lawson Health Research Institute
研究点 (1)
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