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

NCT ID: NCT03612492

Last Updated: 2019-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-07-31

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.

Conditions

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Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Esmolol Group

Patients will receive esmolol during induction of anesthesia

Group Type ACTIVE_COMPARATOR

Esmolol

Intervention Type DRUG

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

Intervention Type DRUG

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.

Lidocaine Group

Patients will receive lidocaine during induction of anesthesia

Group Type ACTIVE_COMPARATOR

Esmolol

Intervention Type DRUG

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Beta blocker Local anesthetic

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital de Base

OTHER

Sponsor Role lead

Responsible Party

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Fabricio Tavares Mendonca

Preceptor of Medical Residency in Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital de Base do Distrito Federal

Brasília, Federal District, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Jamil Elias, MD

Role: primary

556133151588

Viviane Rezende, MD

Role: backup

556133151331

References

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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.

Reference Type BACKGROUND
PMID: 25885726 (View on PubMed)

Mendonca FT, de Queiroz LM, Guimaraes 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.

Reference Type BACKGROUND
PMID: 28017170 (View on PubMed)

Other Identifiers

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Esmolol vs Lidocaine on OTI

Identifier Type: -

Identifier Source: org_study_id

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