EUCTR2015-002366-23-AT进行中(未招募)1 期
Goal-directed heart rate control during emergence from anesthesia using esmolol to attenuate myocardial injury in patients undergoing non-cardiac surgery
Medical University of Vienna, Department of Anaesthesia, General Intensive Care and Pain Management0 个研究点目标入组 140 人开始时间: 2015年8月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •= 45 years
- •scheduled for elective major non-cardiac surgery
- •general anesthesia (using general anesthetic drug(s) and opioids)
- •anticipated postoperative hospital stay for > 2 days
- •no treatment with ß-receptor blocking drugs for more than 30 days
- •increased cardiovascular risk because of history of coronary artery disease or a combination of = 2 of the following risk factors: = 70 years, congestive heart failure (NYHA = II), chronic renal failure, smoking history, hypertension, diabetes, lipid-lowering drug treatment or hypercholesterolemia, and obesity (BMI > 35).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •patients who do not understand the informed consent
- •spinal or epidural anesthesia
- •history of ischemic cerebrovascular disease
- •severe asthma and COPD
- •preoperative heart rate <61 beats per minute (bpm)
- •cardiac pacemaker
- •atrioventricular block type 2 and 3
- •sick sinus syndrome
- •sinoatrial block
- •cardiogenic shock
- •congestive heart failure (NYHA III or IV)
- •pulmonary hypertension
- •untreated pheochromocytoma
- •pulmonary edema
- •persons with increased vulnerability (e.g. cognitive limitations)
- •pregnant, or breast-feeding
- •current administration of cardiodepressant calcium channel antagonists, cardiac glycosides (digoxin, digitoxin) ), or If-inhibitors (such as ivabradin)
- •end-stage liver disease
- •intolerances or hypersensitivity reactions to study drug
- •previous participation in the study
- •participation in another, possibly interfering trial
研究者
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