Patients With Low Cardiac Output Syndrome Undergoing Local Dental Anesthesia

Cardiovascular Events in Patients With Low Cardiac Output Undergoing Local Dental Anesthesia With and Without Epinephrine: Randomized, Double-blind Pilot Study

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06355882

Enrollment

Registered

2024-04-10

Start date

2023-08-08

Completion date

2024-12-01

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Cardiac Output Syndrome

Brief summary

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

Interventions

PROCEDUREAnesthetic infiltration

Application of local dental anesthesia with two cartridges (3,6 mL) for dental procedures (tooth extraction or periodontal treatment) in patients with low cardiac output syndrome.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Amount ventricular and supraventricular arrhythmia	during dental procedures	Number of ventricular and supraventricular arrhythmias recorded using Holter

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026