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

May 24, 2019 updated by: Fabricio Tavares Mendonca, Hospital de Base

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • DF
      • Brasilia, DF, Brazil, 70680250
        • Recruiting
        • Hospital de Base do Distrito Federal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with tachycardia after intubation
Time Frame: 12 minutes
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
Time Frame: 12 minutes
Hemodynamic stability analysis through the incidence of tachycardia, hypertension, bradycardia, hypotension
12 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Base

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

July 31, 2019

Study Completion (Anticipated)

July 31, 2019

Study Registration Dates

First Submitted

July 25, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 24, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Esmolol vs Lidocaine on OTI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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