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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03612492
Enrollment
80
Registered
2018-08-02
Start date
2018-07-01
Completion date
2019-07-31
Last updated
2019-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability

Keywords

esmolol, lidocaine, intubation, hemodynamic response

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.

Interventions

DRUGEsmolol

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.

DRUGLidocaine

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.

Sponsors

Hospital de Base
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with tachycardia after intubation12 minutesAnalysis of the incidence of tachycardia after intubation

Secondary

MeasureTime frameDescription
Number of participants with adverse events as a measure of safety and tolerability12 minutesHemodynamic stability analysis through the incidence of tachycardia, hypertension, bradycardia, hypotension

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026