CClinicalTrials.gg
Status unknownNCT04264286Updated Feb 11, 2020

The Effects of Esmolol on the Hemodynamic Response to Orotracheal Extubation

A Phase 4 interventional study of Prophylactic esmolol and Placebo in Beta Blocker and Hemodynamic Instability, sponsored by Hospital de Base. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-11.

Sponsored by Hospital de Base · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jul 2019, registered Feb 2020).
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Beta Blocker
  • Hemodynamic Instability

Keywords

  • Esmolol
  • Extubation
  • Hemodynamic instability
03

In context

Lead sponsor

Hospital de Base is the lead sponsor of 24 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Esmolol group

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

    Drug: Prophylactic esmolol

  • Placebo comparator
    Placebo group

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

    Drug: Placebo

Interventions

  • DrugProphylactic esmolol

    Patients will receive prophylactic esmolol after the end of the surgery

  • DrugPlacebo

    Patients will prophylactic placebo after the end of the surgery

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events as tachycardia

    Intraoperative hemodynamic stability analysis through the incidence tachycardia

    Time frame: Through study completion, an average of 15 minutes (during awakening from anesthesia)

07

Study locations

1 of 1 sites recruiting
  • Hospital de Base do Distrito Federal
    Brasília, DF 70335900, Brazil
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04264286
Lead sponsor
Hospital de Base
Responsible party
Fabricio Tavares Mendonca (Preceptor of Medical Residency in Anesthesiology, Hospital de Base) — Principal investigator
First posted
Feb 11, 2020
Start date
Jul 1, 2019
Primary completion
Jul 2020 (estimated)
Completion
Jul 2020 (estimated)
Last update
Feb 11, 2020

Study contacts

Fabricio T Mendonça, MD, MSc
Contact
correiodofabricio@gmail.com
5561981882640
Fabricio T Mendonça, MD, MSc
principal investigator · Hospital de Base do Distrito Federal

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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