The Effects of Esmolol on the Hemodynamic Response to Orotracheal Extubation

The Effects of Esmolol on the Hemodynamic Response to Orotracheal Extubation: a Prospective, Randomized, Double-blind and Placebo-controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Hemodynamic Instability; Beta Blocker
• Intervention / Treatment: Drug: Prophylactic esmolol; Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Fabricio T Mendonça, MD, MSc; Phone Number: 5561981882640; Email: correiodofabricio@gmail.com

Study Locations

• Brazil
  • DF
    • Brasília, DF, Brazil, 70335900
      • Recruiting
      • Hospital de Base do Distrito Federal
      • Contact: Nadja Gloria C Graça, MD; Phone Number: 556133151588; Email: uamphbdf@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Esmolol group; Patients will receive intravenous esmolol after the end of the surgical procedure.	Drug: Prophylactic esmolol; Patients will receive prophylactic esmolol after the end of the surgery
PLACEBO_COMPARATOR: Placebo group; Patients will receive intravenous saline after the end of the surgical procedure.	Drug: Placebo; Patients will prophylactic placebo after the end of the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events as tachycardia	Intraoperative hemodynamic stability analysis through the incidence tachycardia	Through study completion, an average of 15 minutes (during awakening from anesthesia)

Collaborators and Investigators

• Sponsor: Hospital de Base
• Investigators: Principal Investigator: Fabricio T Mendonça, MD, MSc, Hospital de Base do Distrito Federal

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ANTICIPATED): July 1, 2020
• Study Completion (ANTICIPATED): July 1, 2020

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 8, 2020
• First Posted (ACTUAL): February 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 8, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Esmolol; Extubation; Hemodynamic instability
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic beta-1 Receptor Antagonists; Esmolol
• Other Study ID Numbers: Esmolol and extubation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No