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 .

Goal-directed heart rate control during emergence from anesthesia using esmolol to attenuate myocardial injury in patients undergoing non-cardiac surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002366-23-AT

Enrollment

140

Registered

2015-08-27

Start date

2015-10-13

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myocardial damage

Interventions

Trade Name: Esmolol Amomed 2500 mg/10ml Product Name: Esmolol Amomed 2500 mg/10ml Pharmaceutical Form: Infusion INN or Proposed INN: ESMOLOL HYDROCHLORIDE CAS Number: 81161-17-3 Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the efficacy of goal-directed heart rate control to attenuate cardiac troponin plasma level elevation after non-cardiac surgery using the ultra-short acting ß-blocker esmolol during emergence from anesthesia and during post-anesthesia care.;Secondary Objective: To determine the feasibility of goal-directed heart rate control using the ultra-short acting ß-blocker esmolol.;Primary end point(s): Myocardial injury measured as the peak postoperative hs-cTnT.;Timepoint(s) of evaluation of this end point: After surgery until postoperative day 3	—

Measure

Time frame

Main Objective: To determine the efficacy of goal-directed heart rate control to attenuate cardiac troponin plasma level elevation after non-cardiac surgery using the ultra-short acting ß-blocker esmolol during emergence from anesthesia and during post-anesthesia care.;Secondary Objective: To determine the feasibility of goal-directed heart rate control using the ultra-short acting ß-blocker esmolol.;Primary end point(s): Myocardial injury measured as the peak postoperative hs-cTnT.;Timepoint(s) of evaluation of this end point: After surgery until postoperative day 3

—

Secondary

Measure	Time frame
Secondary end point(s): Mean heart rate;Timepoint(s) of evaluation of this end point: During anesthesia and at PACU	—

Countries

Austria

Contacts

Public ContactClinical Trials Information PI

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

andreas.duma@meduniwien.ac.at+43(0)14040041000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 26, 2026