Patients With Low Cardiac Output Syndrome Undergoing Local Dental Anesthesia
Not Applicable
Recruiting
- Conditions
- Low Cardiac Output Syndrome
- Interventions
- Procedure: Anesthetic infiltration
- Registration Number
- NCT06355882
- Lead Sponsor
- University of Sao Paulo General Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 29
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Grupo de estudo (Lidocaine with epinephrine) Anesthetic infiltration Anesthetic lidocaine 2% with epinephrine 1:100.000 Grupo controle (Lidocaine) Anesthetic infiltration Anesthetic lidocaine 2%
- Primary Outcome Measures
Name Time Method Amount ventricular and supraventricular arrhythmia during dental procedures Number of ventricular and supraventricular arrhythmias recorded using Holter
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Instituto do Coração HCFMUSP
🇧🇷São Paulo, Brazil