NCT03612492

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

1.1 years

First QC Date

July 25, 2018

Last Update Submit

May 24, 2019

Conditions

Hemodynamic Instability

Keywords

esmolollidocaineintubationhemodynamic response

Outcome Measures

Primary Outcomes (1)

  • Number of participants with tachycardia after intubation

    Analysis of the incidence of tachycardia after intubation

    12 minutes

Secondary Outcomes (1)

  • Number of participants with adverse events as a measure of safety and tolerability

    12 minutes

Study Arms (2)

Esmolol Group

ACTIVE COMPARATOR

Patients will receive esmolol during induction of anesthesia

Drug: EsmololDrug: Lidocaine

Lidocaine Group

ACTIVE COMPARATOR

Patients will receive lidocaine during induction of anesthesia

Drug: EsmololDrug: Lidocaine

Interventions

EsmololDRUG

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.

Also known as: Beta blocker
Esmolol GroupLidocaine Group
LidocaineDRUG

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.

Also known as: Local anesthetic
Esmolol GroupLidocaine Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Base do Distrito Federal

Brasília, Federal District, 70680250, Brazil

RECRUITING

Related Publications (2)

  • 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.

    PMID: 25885726BACKGROUND

  • 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.

    PMID: 28017170BACKGROUND

MeSH Terms

Interventions

esmololAdrenergic beta-AntagonistsLidocaineAnesthetics, Local

Intervention Hierarchy (Ancestors)

Adrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of DrugsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnestheticsCentral Nervous System DepressantsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Preceptor of Medical Residency in Anesthesiology

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 2, 2018

Study Start

July 1, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

May 29, 2019

Record last verified: 2019-05

Locations

BR(1)