Brevibloc (Esmolol Hydrochloride) - Summary

BREVIBLOC SUMMARY

BREVIBLOC (Esmolol Hydrochloride) is a beta adrenergic receptor blocker with a very short duration of action (elimination half-life is approximately 9 minutes).

Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia

BREVIBLOC (Esmolol Hydrochloride) is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. BREVIBLOC is also indicated in noncompensatory sinus tachycardia where, in the physician's judgment, the rapid heart rate requires specific intervention. BREVIBLOC is intended for short-term use.

Intraoperative and Postoperative Tachycardia and/or Hypertension

BREVIBLOC (Esmolol Hydrochloride) is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, when in the physician's judgment such specific intervention is considered indicated.

Use of BREVIBLOC to prevent such events is not recommended.

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NEWS HIGHLIGHTS

Published Studies Related to Brevibloc (Esmolol)

A randomised study of perioperative esmolol infusion for haemodynamic stability during major vascular surgery; rationale and design of DECREASE-XIII. [2011.09]
OBJECTIVES: This article describes the rationale and design of the DECREASE-XIII trial, which aims to evaluate the potential of esmolol infusion, an ultra-short-acting beta-blocker, during surgery as an add-on to chronic low-dose beta-blocker therapy to maintain perioperative haemodynamic stability during major vascular surgery. DESIGN: A double-blind, placebo-controlled, randomised trial... CONCLUSIONS: This study will provide data on the efficacy of esmolol titration in chronic beta-blocker users for tight heart-rate control and reduction of ischaemia in patients undergoing vascular surgery as well as data on safety parameters. Copyright (c) 2011 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

[A comparative study on the efficacy and safety of intravenous esmolol, amiodarone and diltiazem for controlling rapid ventricular rate of patients with atrial fibrillation during anesthesia period]. [2010.11]
OBJECTIVE: To evaluate the efficacy and safety of intravenous esmolol, amiodarone and diltiazem for controlling rapid ventricular rate in patients with atrial fibrillation (AF) during anesthesia period... CONCLUSIONS: Intravenous esmolol, amiodarone and diltiazem are all equally effective and safe on controlling rapid ventricular rate in patients with atrial fibrillation during the anesthesia period. Esmolol use is associated with the shortest mean reacting time and amiodarone use is associated with the lowest total side effect rate in this patient cohort.

[Effect of intravenous esmolol on BIS index and anesthesia emergence during sedation anesthesia for ambulatory surgery]. [2010.06.15]
CONCLUSION: Esmolol combined with propofol administering in minor ambulatory operations can control the increase of BIS index caused by surgical nociceptive stimulus. Meanwhile the combination could reduce the dose of sedatives and decrease anesthesia emergence time.

Esmolol reduces perioperative ischemia in noncardiac surgery: a meta-analysis of randomized controlled studies. [2010.04]
OBJECTIVE: Literature increasingly has suggested how beta-blockers could be associated with reductions of mortality and morbidity in noncardiac surgery. Recently, the POISE trial showed that beta-blockers could be harmful in the perioperative period. The authors performed a meta-analysis to evaluate the clinical effects of esmolol in noncardiac surgery... CONCLUSIONS: Esmolol seemed to reduce the incidence of myocardial ischemia in noncardiac surgery without increasing the episodes of hypotension and bradycardia. Large randomized trials are necessary to confirm these promising results. Copyright (c) 2010 Elsevier Inc. All rights reserved.

Attenuation of hemodynamic responses to laryngoscopy and tracheal intubation during rapid sequence induction: remifentanil vs. lidocaine with esmolol. [2010.03]
AIM: This study was designed to compare the effectiveness of remifentanil vs. a lidocaine-esmolol combination in blunting the hemodynamic response to laryngoscopy and intubation during rapid sequence induction using thiopental and rocuronium in normotensive patients... CONCLUSION: The results of this study show that remifentanil 1 mg/kg is more effective than the combination of lidocaine 1.5 mg/kg and esmolol 1 mg/kg for attenuating the hemodynamic responses to rapid sequence intubation.

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Clinical Trials Related to Brevibloc (Esmolol)

Esmolol Effects on Heart and Inflammation in Septic Shock [Recruiting]
Beta adrenergic system, over-activated in septic shock patients, is a key modulator of the inflammatory response. Experimental works demonstrated that Esmolol, an highly selective beta-1 blocker, reduces heart rate and regulates the inflammatory response. A recent mono centric, double blind, randomized clinical work in septic shock patients has shown that Esmolol administration is safe and reduces effectively heart rate. However there are only sparse data on 1) regional and micro-circulation, 2) inflammation modulation in human resuscitated septic shock patients treated by esmolol.

A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol in Intracranial Surgery [Completed]
It was hypothesized that the use of esmolol as an alternative to remifentanil with sevoflurane inhalation anesthesia during intracranial surgery, could provide better hemodynamic conditions and cause lesser side effects in the perioperative period. It was the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension and the intraoperative fentanyl consumption. The comparison of postoperative troponine I and creatine phosphokinase levels and EKG changes were the secondary objectives.

Effect of Esmolol on Pain Due to Rocuronium [Not yet recruiting]
90 American society of anesthesiology (ASA) physical status I and II patients undergoing general anesthesia for elective surgery will be included in the study. Patients will be randomized into three groups. Group E will receive esmolol (1 mg/kg), Group IL lidocaine (1. 5 mg/kg)and Group C placebo(NaCl 0. 9%, 5 mL), followed by a 0. 05 mg/kg rocuronium. After intravenous induction with propofol, adequate muscle relaxation for intubation will be received by 0. 5 mg/kg rocuronium.

Long-term PK and Safety/Tolerability Testing LDLL600 Against Esmolol in Healthy Volunteers [Completed]
The study will compare the pharmacokinetics (PK), safety and tolerability of long-term infusion of lyophilized landiolol (LDLL600) against esmolol (Brevibloc) by measurement of blood concentrations of landiolol, esmolol and their metabolites, and by monitoring systemic cardiovascular and local tolerability, blood pressure (BP), ECG including heart rate (HR) and adverse events (AEs).

Labetalol and Esmolol: Vital Signs and Post Operative Pain Management [Recruiting]
This study proposes to investigate the effects of labetalol or esmolol on managing the vital signs (like blood pressure and heart rate) during surgery, on pain management, and on the later recovery after surgery. It will also assess the cost-effectiveness of Labetalol and esmolol for outpatient surgery.

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