BREVIBLOC SUMMARY
BREVIBLOC (Esmolol Hydrochloride) is a beta1-selective (cardioselective) adrenergic receptor blocking agent with a very short duration of action (elimination half-life is approximately 9 minutes). Esmolol Hydrochloride is:
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 not intended for use in chronic settings where transfer to another agent is anticipated.
BREVIBLOC (Esmolol Hydrochloride) is indicated for the 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.
Clinical Trials Related to Brevibloc (Esmolol)
A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol in Intracranial Surgery [Recruiting]
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 cretine phosphokinase levels and EKG changes
were the secondary objectives.
Study to Evaluate Esmolol (Brevibloc) to Manage Cardiac Function in Patients With Subarachnoid Hemorrhage [Recruiting]
The purpose of this study is to evaluate the clinical effect of esmolol treatment on cardiac
function and electrophysiology; to assess the effects of esmolol treatment on serum
adrenergic and cardiac biomarkers; to explore the safety of esmolol treatment shortly after
subarachnoid hemorrhage (SAH). Patients will be followed for a maximum of 1 month after the
index SAH. The primary outcome will be change in systolic function - ejection fraction by
Simpson's rule (baseline versus Day 7 +/- 2 after SAH).
Long-term PK and Safety/Tolerability Testing LDLL600 Against Esmolol in Healthy Volunteers [Recruiting]
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).
Esmolol Infusion During Laminectomy: Effect on Quality of Recovery [Recruiting]
The purpose of this study is to evaluate the effects of esmolol, a drug which is commonly
administered during surgery to help control blood pressure and heart rate, on postoperative
pain levels and requirements for pain medication.
The Effect of Intraoperative Esmolol to Improve Postoperative Quality of Recovery and Pain After Ambulatory Surgery [Recruiting]
Seventy percent of surgeries performed in the United States are done in an outpatient
setting. Pain Control after ambulatory surgery is very challenging because patients do not
have access to fast and potent intravenous medications Pain after ambulatory surgery is
poorly controlled in the United States with up to seventy five percent of patients having
moderate to severe pain after ambulatory procedures. Postoperative pain have been associated
with serious morbidity, including myocardial infarction and pulmonary embolism.
The use of intraoperative opioids can result in an exaggerated response to pain
(hyperalgesia) and contribute to an exacerbation of pain after surgical procedures. Opioids
are commonly given intraoperative, not in response to pain, but in response to hyperdynamic
cardiovascular states. Esmolol is a short acting beta 1 antagonist that can be used to
treat/prevent hyperdynamic states during surgery. More importantly, esmolol has been shown
to have central antihyperalgesic effects that might contribute to a reduction in
postoperative pain. It is therefore conceivable that the use of intraoperative esmolol
instead of opioids to avoid hyperdynamic states during surgery can result in lower
postoperative pain. Since postoperative pain can substantially affect postoperative quality
of recovery, it is also conceivable that the use of intraoperative esmolol might result in
an improved postoperative quality of recovery to surgical patients.
The main objective of the current study is to examine the effect of intraoperative esmolol
on postoperative quality of recovery. A secondary objective is to examine the effect of
esmolol on postoperative pain.
Significance: Postoperative pain after ambulatory surgery has been shown to be poorly
managed in The United States. The goal of this study is to investigate if a change in the
intraoperative pharmacologic management of patients undergoing ambulatory surgery can
improve their postoperative quality of recovery and pain.
The research question is; does the use of intraoperative esmolol improve postoperative
quality of recovery after ambulatory surgery? Does the use of intraoperative esmolol improve
postoperative pain after ambulatory surgery?
The hypotheses of this study is; does the use of intraoperative esmolol improves
postoperative quality of recovery after ambulatory surgery. The use of intraoperative
esmolol reduces postoperative pain after ambulatory surgery.
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