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The Effects of Lidocaine and Esmolol on Attenuation of Hemodynamic Response to Orotracheal Intubation

Phase 4
Conditions
Hemodynamic Instability
Interventions
Registration Number
NCT03612492
Lead Sponsor
Hospital de Base
Brief Summary

The present study aims to compare the hemodynamic response during laryngoscopy and orotracheal intubation using continuous infusion of lidocaine and esmolol in patients undergoing general anesthesia.

Detailed Description

Esmolol is a selective beta-blocker of fast action that antagonizes beta-1 adrenergic receptors. Venous lidocaine is the agent most used to attenuate the hemodynamic response to laryngoscopy and intubation, in addition to cough reflex.

Objective: To compare the hemodynamic response during laryngoscopy and orotracheal intubation using continuous infusion of lidocaine and esmolol.

Methods: Randomized, double masked clinical trial aims to compare the effect of esmolol and lidocaine on orotracheal intubation. All patients will receive balanced general anesthesia. One group (EG) will receive bolus esmolol of 1.5mg / kg in 10 min following by continuous infusion at a rate of 0.1mg / kg / min. The lidocaine (LG) group will receive lidocaine bolus of 1.5mg / kg in 10 min following by continuous infusion at a rate of 1.5mg / kg / h.

Data on hemodynamic changes, reaction to laryngoscopy, conditions at intubation and adverse events will be evaluated.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
80
Inclusion Criteria
  • Patients aged between 18 and 70 years
  • Physical State 1, 2 or 3 of the American Society of Anesthesiology (ASA)
  • Electively or urgently scheduled for surgery requiring general anesthesia, with programming of orotracheal intubation via direct laryngoscopy at the Base Hospital of the Federal District.
Exclusion Criteria
  • Patients younger than 18 and over 70 years of age
  • Patients with contraindications or history of hypersensitivity to the drugs involved in the study
  • Patients with coronary ischemic disease
  • Patients with atrioventricular block at any grade
  • Patients with diagnosed cardiac arrhythmias
  • Patients with heart failure
  • Patients who are beta-blockers or calcium channel blockers
  • Patients with renal insufficiency of any kind
  • Patients with difficulty predicting orotracheal intubation
  • Patients with BMI ≥ 35 kg / m²
  • Patients who underwent neuroaxis block before anesthetic induction
  • Patients who refuse to participate in the study after submitting the informed consent form
  • Patients requiring two or more attempts of laryngoscopy for positioning of the orotracheal tube
  • Patients with asthma
  • Any other condition that, in the opinion of the researcher, may pose a risk to the patient or interfere with the objectives of the study

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Esmolol GroupEsmololPatients will receive esmolol during induction of anesthesia
Lidocaine GroupEsmololPatients will receive lidocaine during induction of anesthesia
Esmolol GroupLidocainePatients will receive esmolol during induction of anesthesia
Lidocaine GroupLidocainePatients will receive lidocaine during induction of anesthesia
Primary Outcome Measures
NameTimeMethod
Number of participants with tachycardia after intubation12 minutes

Analysis of the incidence of tachycardia after intubation

Secondary Outcome Measures
NameTimeMethod
Number of participants with adverse events as a measure of safety and tolerability12 minutes

Hemodynamic stability analysis through the incidence of tachycardia, hypertension, bradycardia, hypotension

Trial Locations

Locations (1)

Hospital de Base do Distrito Federal

🇧🇷

Brasilia, DF, Brazil

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