Novel Strategy For Perioperative Beta-Blocker Therapy - Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Difference in hscTnI Values
研究概览
简要总结
Perioperative cardiac adverse events [heart injuries caused by general anesthesia and surgical procedures] are a significant public health issue, with more than 60,000 deaths per annum in patients having surgery for non-heart related issues. There are virtually no evidence-based medical strategies for effective prevention of these events. Preoperative drug treatment with beta blockade drugs used for high blood pressure, perioperative therapy with lipid lowering drugs such as statins, alpha-receptor agonists such as clonidine used for high blood pressure, and aspirin have all been investigated as potential mitigating treatments, but without positive clinical outcomes and, in some cases, creating more hemodynamic instabilities that result in heart injury. In light of this, investigators propose to evaluate the safety and efficacy of using increasing doses of beta blockade drugs immediately after surgery and to assess the value of high-sensitivity cardiac troponin level testing of the blood in predicting those patients who would benefit most from perioperative beta blocker therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 51 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >50 years
- •American Society of Anesthesiologists (ASA) risk status III-IV
- •Revised Cardiac Risk Index ≥2
- •β-blocker naïve (not having received β-blocker within 30 days prior to surgery)
- •Previously diagnosed coronary artery disease (CAD) or at high risk for CAD:
- •History of peripheral vascular disease, or
- •Diabetes and currently on oral anti-diabetic drug or insulin therapy, or
- •Chronic renal failure (eGFR <30 m/min)
- •Major non-cardiac surgery under general anesthesia
排除标准
- •History of stroke
- •Heart rate <55bpm
- •Heart failure
- •Second or third degree AV block without pacemaker
- •Active asthma or COPD
- •Anemia [Hb<9g/dL]
- •Allergy to beta-blockade drugs
- •Hemodynamic instability
- •Uncontrolled hemorrhage
- •Unwilling or unable to give consent for participation
研究组 & 干预措施
treatment
Postsurgical: 5mg metoprolol, IV, prior to extubation, every 5 minutes to achieve target heart rate of 65/min, up to 15mg; then 25mg metoprolol, oral, every 8 hours for 72 hours.
干预措施: metoprolol (Drug)
结局指标
主要结局
Difference in hscTnI Values
时间窗: Before surgery and Immediately after surgery (on the day of surgery)
Difference in hscTnI concentrations between preoperative clinic visit and day of surgery
次要结局
未报告次要终点