Reduction of cardiac damage by controlling heart rate with an intravenous medication called esmolol during emergence from anesthesia and in the postanesthesia care unit in patients who undergo non-cardiac surgery .

Phase 1

Conditions: myocardial damage
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2015-002366-23-AT

Lead Sponsor: Medical University of Vienna, Department of Anaesthesia, General Intensive Care and Pain Management

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

•= 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

Exclusion Criteria

•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