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Patients With Low Cardiac Output Syndrome Undergoing Local Dental Anesthesia

U

University of Sao Paulo General Hospital

Status

Enrolling

Conditions

Low Cardiac Output Syndrome

Treatments

Procedure: Anesthetic infiltration

Study type

Interventional

Funder types

Other

Identifiers

NCT06355882
LCOSDental

Details and patient eligibility

About

Patients with low cardiac output syndrome requiring surgical and periodontal dental treatment will be selected to undergo the dental procedure using local dental anesthetic: 2% lidocaine with epinephrine and 2% lidocaine without vasoconstrictor. Cardiovascular events and the safety of using two cartridges (3.6 mL) will be evaluated. They will be evaluated by Holter monitoring in the period of 1 hour before, during and 1 hour after the procedure and blood pressure correction will be performed

Enrollment

29 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with advanced heart failure, in INTERMACS III using dobutamine at 5 to 20 µg/kg/minute due to low cardiac output syndrome
  • Presence of periodontal disease, in the 4th or 6th sextant with indication of supragingival and/or subgingival periodontal scaling;
  • Residual root or teeth with periodontal disease in the jaw, with simple extraction indicated.

Exclusion criteria

  • Patients with a ventricular assist device such as an intra-aortic balloon implanted less than 24 hours after the dental procedure or with extracorporeal membrane oxygenation (ECMO);
  • Using other inotropes;
  • On mechanical ventilation;
  • Continuously using a non-invasive ventilation mask;
  • In septic shock;
  • Presence of acute myocardial infarction <30 days;
  • Patients with terminal non-cardiac disease, cyanotic congenital heart disease or cardiomyopathies with arrhythmogenic potential (arrhythmogenic dysplasia, hypertrophic cardiomyopathy, non-compacted myocardium);
  • Pregnant women;
  • History of sudden death recovered < 1 month ago;
  • In the recent postoperative period of cardiac surgery (5 days);
  • Allergic to sodium bisulfite and methylparaben, preservatives of epinephrine and the anesthetic cartridge, respectively.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

29 participants in 2 patient groups

Grupo de estudo (Lidocaine with epinephrine)
Active Comparator group
Description:
Anesthetic lidocaine 2% with epinephrine 1:100.000
Treatment:
Procedure: Anesthetic infiltration
Grupo controle (Lidocaine)
Active Comparator group
Description:
Anesthetic lidocaine 2%
Treatment:
Procedure: Anesthetic infiltration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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