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临床试验/EUCTR2015-002366-23-AT
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

发起方
Medical University of Vienna, Department of Anaesthesia, General Intensive Care and Pain Management

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