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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemodynamic Instability

Intervention / Treatment
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* Drug: Esmolol
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Esmolol Group<br>Patients will receive esmolol during induction of anesthesia | Drug: Esmolol<br>* 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.<br>* Other names: Beta blocker;Drug: Lidocaine<br>* 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.<br>* Other names: Local anesthetic;|
| Active Comparator: Lidocaine Group<br>Patients will receive lidocaine during induction of anesthesia | Drug: Esmolol<br>* 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.<br>* Other names: Beta blocker;Drug: Lidocaine<br>* 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.<br>* Other names: Local anesthetic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with tachycardia after intubation | Analysis of the incidence of tachycardia after intubation | 12 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esmolol, lidocaine, intubation, hemodynamic response