High-risk, Non-cardiovascular Surgeries Clinical Trial
Official title:
Safety and Efficacy of Esmolol for the Treatment of Peri-operative Tachycardia in Patients at Risk for Post Operative Adverse Ischemic Outcomes
The purpose of this study is to find out if Esmolol is a safe and effective alternative treatment compared to standard treatment using a long acting beta blocker drug, in controlling abnormal heart rate before, during and immediately after surgery.
The benefit versus risk of perioperative beta blockade therapy for adverse ischemic event
risk reduction in high risk patients undergoing non-cardiac surgery has been recently
challenged. In particular the PeriOperative Ischemia Study Evaluation (POISE trial) showed a
cardio-protective effect only at the expense of a higher incidence of stroke and all-cause
mortality . In that study death and stroke were significantly associated with an increase in
hypotension and bradycardia. Long acting agents - aggressively administered to achieve heart
rate (HR) control - appear to be associated with significant adverse outcomes (death,
stroke) despite myocardial ischemia and infarction reduction.
It is estimated that 20 percent of high risk patients come to surgery with chronic beta
blocker oral therapy. The American Heart Association recommends continuation of beta
blockers in this situation as beta-blocker withdrawal is associated with increased rate of
perioperative myocardial infarction . Protocols optimizing the perioperative administration
of beta-blockers in high-risk patients are therefore needed.
Esmolol is a cardioselective beta-blocker with a short elimination half-life (t1/2 = 9.2
min) and no intrinsic sympathomimetic activity. Evidence has revealed that Esmolol, with its
unique short half life can be quickly titrated to both achieve a target hemodynamic effect
as well as reduce (or loose) its effect quickly in unstable situations thereby mitigates
undesired hypotension and / or bradycardia.
This study proposes to assess the Safety and Efficacy of dosing to target endpoints with
Esmolol - an ultra short acting beta blocker - the day of surgery compared to standard long
acting oral Metoprolol the day of surgery.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment