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

H

Hospital de Base

Status and phase

Unknown
Phase 4

Conditions

Hemodynamic Instability

Treatments

Drug: Lidocaine
Drug: Esmolol

Study type

Interventional

Funder types

Other

Identifiers

NCT03612492
Esmolol vs Lidocaine on OTI

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups

Esmolol Group
Active Comparator group
Description:
Patients will receive esmolol during induction of anesthesia
Treatment:
Drug: Esmolol
Drug: Lidocaine
Lidocaine Group
Active Comparator group
Description:
Patients will receive lidocaine during induction of anesthesia
Treatment:
Drug: Esmolol
Drug: Lidocaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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