The Effects of Esmolol on the Hemodynamic Response to Orotracheal Extubation: a Prospective, Randomized, Double-blind and Placebo-controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Hospital de Base
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Number of participants with adverse events as tachycardia
Study Overview
Brief Summary
Beta-blockers are useful tools for the prevention of hemodynamic instability in the manipulation of airways. The main objective of the present study is to evaluate the effectiveness of using esmolol in attenuating hemodynamic responses at the time of tracheal extubation, by assessing the incidence of tachycardia in relation to placebo.
Detailed Description
The moment of extubation represents a critical period of anesthesia where important hemodynamic changes occur. These occur due to stimulation of the larynx, trachea and bronchi that generates an increased release of catecholamines. In high-risk patients, these hemodynamic changes can have serious consequences.
Many strategies have been used to control the hemodynamic response to airway manipulation during the period of intubation, but until today there is no standard therapy for this control during the period of extubation. Therefore, the investigators aim to study the use of beta-blockers in this context.
Beta-blockers are an attractive pharmacological strategy as they reduce the activation of the sympathetic nervous system proper at this time. Esmolol, due to its short half-life, can be an ideal tool to ensure better hemodynamic control.
There are few studies in the literature that study this drug during extubation, and there is no consensus on the best dose or method of administration for this moment.
Therefore, this study aims to evaluate the effectiveness of using esmolol in attenuating hemodynamic responses at the time of tracheal extubation, by assessing the incidence of tachycardia in relation to placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients aged between 18 and 60 years, electively scaled for surgery requiring general anesthesia.
- •Physical State 1, 2 or 3 of the American Society of Anesthesiology (ASA)
Exclusion Criteria
- •Patients with cardiac disease
- •Patients with renal disease
- •Patients with liver disease
- •Patient with lung disease
- •Patients using beta blockers or calcium channel blockers
- •Patients who refuse to participate in the study after presenting the informed consent form
Arms & Interventions
Esmolol group
Patients will receive intravenous esmolol after the end of the surgical procedure.
Intervention: Prophylactic esmolol (Drug)
Placebo group
Patients will receive intravenous saline after the end of the surgical procedure.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of participants with adverse events as tachycardia
Time Frame: Through study completion, an average of 15 minutes (during awakening from anesthesia)
Intraoperative hemodynamic stability analysis through the incidence tachycardia
Secondary Outcomes
No secondary outcomes reported
Investigators
Fabricio Tavares Mendonca
Preceptor of Medical Residency in Anesthesiology
Hospital de Base