Patients With Low Cardiac Output Syndrome Undergoing Local Dental Anesthesia

NCT06355882 | Recruiting DMC

• 1 other identifier: LCOSDental
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Conditions

Low Cardiac Output Syndrome

Outcome Measures

Primary Outcomes (1)

• Amount ventricular and supraventricular arrhythmia

  Number of ventricular and supraventricular arrhythmias recorded using Holter

  during dental procedures

Study Arms (2)

Grupo de estudo (Lidocaine with epinephrine)

ACTIVE COMPARATOR

Anesthetic lidocaine 2% with epinephrine 1:100.000

Procedure: Anesthetic infiltration

Grupo controle (Lidocaine)

ACTIVE COMPARATOR

Anesthetic lidocaine 2%

Procedure: Anesthetic infiltration

Interventions

Anesthetic infiltration PROCEDURE

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.

Grupo controle (Lidocaine); Grupo de estudo (Lidocaine with epinephrine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Instituto do Coração HCFMUSP

São Paulo, 05403000, Brazil

RECRUITING

Related Publications (15)

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  PMID: 30379264 BACKGROUND

• Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW. 2009 focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the International Society for Heart and Lung Transplantation. Circulation. 2009 Apr 14;119(14):e391-479. doi: 10.1161/CIRCULATIONAHA.109.192065. Epub 2009 Mar 26. No abstract available.

  PMID: 19324966 BACKGROUND

• Bacal F, Marcondes-Braga FG, Rohde LEP, Xavier Junior JL, Brito FS, Moura LAZ, Colafranceschi AS, Lavagnoli CFR, Gelape CL, Almeida DR, Gaiotto FA, Atik FA, Figueira FAMS, Souza GEC, Rodrigues H, Campos IW, Souza Neto JD, Rossi Neto JM, Gasparetto J, Goldraich LA, Benvenuti LA, Seguro LFBC, Ulhoa Junior MB, Moreira MDCV, Avila MS, Carneiro R, Mangini S, Ferreira SMA, Strabelli TM. 3 feminine Diretriz Brasileira de Transplante Cardiaco. Arq Bras Cardiol. 2018 Aug;111(2):230-289. doi: 10.5935/abc.20180153. No abstract available. Portuguese.

  PMID: 30335870 BACKGROUND

• Oliveira ACG, Neves ILI, Sacilotto L, Olivetti NQS, Santos-Paul MAD, Montano TCP, Carvalho CMA, Wu TC, Grupi CJ, Barbosa SA, Pastore CA, Samesima N, Hachul DT, Scanavacca MI, Neves RS, Darrieux FCC. Is It Safe for Patients With Cardiac Channelopathies to Undergo Routine Dental Care? Experience From a Single-Center Study. J Am Heart Assoc. 2019 Aug 6;8(15):e012361. doi: 10.1161/JAHA.119.012361. Epub 2019 Jul 19.

  PMID: 31319747 BACKGROUND

• Laragnoit AB, Neves RS, Neves IL, Vieira JE. Locoregional anesthesia for dental treatment in cardiac patients: a comparative study of 2% plain lidocaine and 2% lidocaine with epinephrine (1:100,000). Clinics (Sao Paulo). 2009;64(3):177-82. doi: 10.1590/s1807-59322009000300005.

  PMID: 19330241 BACKGROUND

• Neves IL, Avila WS, Neves RS, Giorgi DM, Santos JF, Oliveira Filho RM, Grupi CJ, Grinberg M, Ramires JA. Maternal-fetal monitoring during dental procedure in patients with heart valve disease. Arq Bras Cardiol. 2009 Nov;93(5):463-742. doi: 10.1590/s0066-782x2009001100005.

  PMID: 20084307 BACKGROUND

• Neves RS, Neves IL, Giorgi DM, Grupi CJ, Cesar LA, Hueb W, Grinberg M. Effects of epinephrine in local dental anesthesia in patients with coronary artery disease. Arq Bras Cardiol. 2007 May;88(5):545-51. doi: 10.1590/s0066-782x2007000500008. English, Portuguese.

  PMID: 17589629 BACKGROUND

• Ruffolo RR Jr. The pharmacology of dobutamine. Am J Med Sci. 1987 Oct;294(4):244-8. doi: 10.1097/00000441-198710000-00005.

  PMID: 3310640 BACKGROUND

• Leier CV, Webel J, Bush CA. The cardiovascular effects of the continuous infusion of dobutamine in patients with severe cardiac failure. Circulation. 1977 Sep;56(3):468-72. doi: 10.1161/01.cir.56.3.468.

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  PMID: 14076341 BACKGROUND

• Dajani AS, Taubert KA, Wilson W, Bolger AF, Bayer A, Ferrieri P, Gewitz MH, Shulman ST, Nouri S, Newburger JW, Hutto C, Pallasch TJ, Gage TW, Levison ME, Peter G, Zuccaro G Jr. Prevention of bacterial endocarditis: recommendations by the American Heart Association. J Am Dent Assoc. 1997 Aug;128(8):1142-51. doi: 10.14219/jada.archive.1997.0375.

  PMID: 9260427 BACKGROUND

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 10, 2024
• Study Start: August 8, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

BR (1)