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

Sponsor

Hospital de Base (Other)

Overall Status

Unknown status

CT.gov ID

NCT03612492

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodynamic Instability	Drug: Esmolol Drug: Lidocaine	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 1, 2018

Anticipated Primary Completion Date :

Jul 31, 2019

Anticipated Study Completion Date :

Jul 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Esmolol Group Patients will receive esmolol during induction of anesthesia	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. Other Names: Beta blocker Drug: 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. Other Names: Local anesthetic
Active Comparator: Lidocaine Group Patients will receive lidocaine during induction of anesthesia	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. Other Names: Beta blocker Drug: 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. Other Names: Local anesthetic

Arm

Intervention/Treatment

Active Comparator: Esmolol Group

Patients will receive esmolol during induction of anesthesia

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.

Other Names:

Beta blocker

Drug: 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.

Other Names:

Local anesthetic

Active Comparator: Lidocaine Group

Patients will receive lidocaine during induction of anesthesia

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.

Other Names:

Beta blocker

Drug: 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.

Other Names:

Local anesthetic

Outcome Measures

Primary Outcome Measures

Number of participants with tachycardia after intubation [12 minutes]
Analysis of the incidence of tachycardia after intubation

Secondary Outcome Measures

Number of participants with adverse events as a measure of safety and tolerability [12 minutes]
Hemodynamic stability analysis through the incidence of tachycardia, hypertension, bradycardia, hypotension

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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