The Effects of Esmolol on the Hemodynamic Response to Orotracheal Extubation

NCT ID: NCT04264286

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-07-31

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.

This prospective, randomized, double-blind, placebo-controlled study aims to verify the hypothesis that esmolol reduces hemodynamic instability induced by tracheal extubation in surgical procedures at Base Hospital of the Federal District. The examiners responsible for patient assessment will not have access to the agents used.

Patients will be randomized through a randomly generated list. The examiner responsible for opening the envelope will make the draw, will include the patient in one of the groups, write down their data in the random list, prepare the syringe with the medication, and deliver it to the operating room so that the next examiners will not be aware of the administered drug.

Patients will receive standard general anesthesia and after the end of the surgical procedure, patients will be allocated the study drug (esmolol 2 mg/kg) or placebo group. All patients will receive sugammadex as a reversal of neuromuscular block and monitored appropriately.

The evolution of vital signs such as systolic blood pressure, mean heart rate, incidence and intensity of adverse events such as cough, bucking, bradycardia, tachycardia, hypertension, hypotension, vasopressor and anticholinergic consumption will be evaluated.

Conditions

Beta Blocker; Hemodynamic Instability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Esmolol group

Patients will receive intravenous esmolol after the end of the surgical procedure.

Group Type: ACTIVE_COMPARATOR

Prophylactic esmolol

Intervention Type: DRUG

Patients will receive prophylactic esmolol after the end of the surgery

Placebo group

Patients will receive intravenous saline after the end of the surgical procedure.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients will prophylactic placebo after the end of the surgery

Interventions

Prophylactic esmolol

Patients will receive prophylactic esmolol after the end of the surgery

Intervention Type: DRUG

Placebo

Patients will prophylactic placebo after the end of the surgery

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital de Base

OTHER

Sponsor Role: lead

Responsible Party

Fabricio Tavares Mendonca

Preceptor of Medical Residency in Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabricio T Mendonça, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Hospital de Base do Distrito Federal

Locations

Hospital de Base do Distrito Federal

Brasília, Federal District, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Fabricio T Mendonça, MD, MSc

Role: CONTACT

correiodofabricio@gmail.com

5561981882640

Facility Contacts

Nadja Gloria C Graça, MD

Role: primary

uamphbdf@gmail.com

556133151588

Viviane Rezende, MD

Role: backup

vrezende@icab.med.br

556133151331

Other Identifiers

Esmolol and extubation

Identifier Type: -

Identifier Source: org_study_id