Dental procedures for patients with low cardiac output syndrome

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

This study tests whether using different types of dental anesthesia is safe for patients with low cardiac output syndrome during dental procedures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Sao Paulo General Hospital (Academic / other)
• Locations: 1 site (São Paulo)
• Trial ID: NCT06355882 on ClinicalTrials.gov

What this trial studies

This study focuses on patients with low cardiac output syndrome who require dental treatments, specifically surgical and periodontal procedures. Participants will receive local dental anesthesia using either 2% lidocaine with epinephrine or 2% lidocaine without vasoconstrictor. The study aims to evaluate cardiovascular events and the safety of using two cartridges of anesthetic during the dental procedures, monitored through Holter monitoring before, during, and after the treatment. Blood pressure adjustments will also be made as necessary.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced heart failure in INTERMACS III who are receiving dobutamine and have periodontal disease requiring dental intervention.

Not a fit: Patients with severe cardiac conditions such as those on mechanical ventilation or with terminal non-cardiac diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the safety and efficacy of dental treatments for patients with low cardiac output syndrome.

How similar studies have performed: While there is limited information on similar studies, the approach of using local anesthesia in patients with cardiac conditions has been explored, though this specific combination is novel.

Eligibility criteria

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.

Where this trial is running

São Paulo

• Instituto do Coração HCFMUSP — São Paulo, Brazil (Recruiting)

Conditions Low Cardiac Output Syndrome