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

Hemodynamic Instability Clinical Trial

Official title:

The Effects of Lidocaine and Esmolol on Attenuation of Hemodynamic Response to Orotracheal Intubation: A Double-blind, Randomized, Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03612492
• Other study ID #: Esmolol vs Lidocaine on OTI
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: May 2019
• Source: Hospital de Base
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

Drug:
• Esmolol
Esmolol group (EG) will receive a bolus of esmolol 1.5mg / kg in 10 min following by continuous infusion at a rate of 0.1mg / kg / min.
• Lidocaine
Lidocaine (LG) group will received lidocaine bolus of 1.5mg / kg in 10 min following by continuous infusion at a rate of 1.5mg / kg / h.

Locations

Country	Name	City	State
Brazil	Hospital de Base do Distrito Federal	Brasilia	DF

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Base

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Mendonça FT, de Queiroz LM, Guimarães CC, Xavier AC. Effects of lidocaine and magnesium sulfate in attenuating hemodynamic response to tracheal intubation: single-center, prospective, double-blind, randomized study. Braz J Anesthesiol. 2017 Jan - Feb;67(1):50-56. doi: 10.1016/j.bjane.2015.08.004. Epub 2016 Nov 22. — View Citation

Singh S, Laing EF, Owiredu WK, Singh A. Comparison of esmolol and lidocaine for attenuation of cardiovascular stress response to laryngoscopy and endotracheal intubation in a Ghanaian population. Anesth Essays Res. 2013 Jan-Apr;7(1):83-8. doi: 10.4103/0259-1162.114008. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with tachycardia after intubation	Analysis of the incidence of tachycardia after intubation	12 minutes
Secondary	Number of participants with adverse events as a measure of safety and tolerability	Hemodynamic stability analysis through the incidence of tachycardia, hypertension, bradycardia, hypotension	12 minutes