Dental Anesthesia in Heart Failure Patients

NCT02228083 | Unknown DMC

• 1 other identifier: InsufCard
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the occurrence of arrhythmias in dental treatment with local anesthetic.

Conditions

Heart Failure

Keywords

dental; epinephrine; local anesthetic; lidocaine; cardiac arrhythmias; procedure

Outcome Measures

Primary Outcomes (1)

• Heart rate (bpm)

  The continuous electrocardiogram recording for a period of 24 hours will be obtained through the Holter monitor model Seer Ligth (GE), with three channels (seven-way) cable, installed a half hour before the dental procedure. The first analysis will be done automatically by the computer system, followed by visual and manual review at which supraventricular and ventricular premature heartbeats will be filtered accurately. Electrocardiographic variables are: heart rate maximum, minimum and mean HR, supraventricular extrasystole (VES) and ventricular (EV) FC. The program shall provide the record in HR per minute for 24 hours. The average individual will be calculated for the period studied, to then calculate the sample mean and groups LSA and LCA. The ESV and EV will be identified in tracing obtained every minute. Consider the valid values recorded HR and ischemic episodes; analyze the occurrence of EV and ESV occurring in number\> 10 per hour in both groups, by study period.

  24 hours

Study Arms (2)

Safety of dental anesthesia

ACTIVE COMPARATOR

Application of local dental anesthesia with two cartridges (5,6 mL) of the lidocaine 2% with epinephrine 1:100.000 in heart failure patients in functional class III or IV.

Drug: Lidocaine with epinephrine

Oral health profile

OTHER

An oral health profile of patients with heart failure will be described based in oral clinical examination.

Drug: Lidocaine with epinephrine

Interventions

Lidocaine with epinephrine DRUG

Lidocaine without vasoconstrictor , lidocaine with epinephrine 1:100,000

Oral health profile; Safety of dental anesthesia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any race,nationality,profession, single or married.
• class II , III or IV of New York heart Association ( NYHA)
• minimum 45% ventricular ejection fraction
• patient must be in a clinical treatment or hospital treatment
• patient must need dental restorative treatment , mandible or maxilla, due to caries or need for substitution of a inadequate dental filling.

You may not qualify if:

• patients with history of heart attack within less than three months
• acute myocardial infarction
• unstable angina
• significant ventricular dysfunction
• severe ventricular arrhythmia
• malignant hypertension
• neoplasms
• sepsis
• pregnancy
• allergy to lidocaine and epinephrine

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Instituto do Coração HCFMUSP

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

Related Publications (17)

• Mann DL. Mechanisms and models in heart failure: A combinatorial approach. Circulation. 1999 Aug 31;100(9):999-1008. doi: 10.1161/01.cir.100.9.999. No abstract available.

  PMID: 10468532 BACKGROUND

• Palatini P, Frigo G, Bertolo O, Roman E, Da Corta R, Winnicki M. Validation of the A&D TM-2430 device for ambulatory blood pressure monitoring and evaluation of performance according to subjects' characteristics. Blood Press Monit. 1998 Aug;3(4):255-260.

  PMID: 10212363 BACKGROUND

• Sivaneswaran S. The oral health of adults in NSW, 2004-06. N S W Public Health Bull. 2009 Mar-Apr;20(3-4):46-51. doi: 10.1071/NB08066.

  PMID: 19401068 BACKGROUND

• SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

  PMID: 14158464 BACKGROUND

• [Guidelines of the Brazilian Cardiology Society to the diagnosis and treatment of heart failure]. Arq Bras Cardiol. 1999 Feb;72 Suppl 1:1-30. No abstract available. Portuguese.

  PMID: 10488571 RESULT

• 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, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American College of Chest Physicians; International Society for Heart and Lung Transplantation; Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005 Sep 20;112(12):e154-235. doi: 10.1161/CIRCULATIONAHA.105.167586. Epub 2005 Sep 13. No abstract available.

  PMID: 16160202 RESULT

• Hunt SA, Baker DW, Chin MH, Cinquegrani MP, Feldman AM, Francis GS, Ganiats TG, Goldstein S, Gregoratos G, Jessup ML, Noble RJ, Packer M, Silver MA, Stevenson LW, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Jacobs AK, Hiratzka LF, Russell RO, Smith SC Jr; American College of Cardiology/American Heart Association. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult: executive summary. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to revise the 1995 Guidelines for the Evaluation and Management of Heart Failure). J Am Coll Cardiol. 2001 Dec;38(7):2101-13. doi: 10.1016/s0735-1097(01)01683-7. No abstract available.

  PMID: 11738322 RESULT

• Hempenstall PD, Campbell JP, Bajurnow AT, Reade PC, McGrath B, Harrison LC. Cardiovascular, biochemical, and hormonal responses to intravenous sedation with local analgesia versus general anesthesia in patients undergoing oral surgery. J Oral Maxillofac Surg. 1986 Jun;44(6):441-6. doi: 10.1016/s0278-2391(86)80008-8.

  PMID: 3009759 RESULT

• Brand HS, Gortzak RA, Abraham-Inpijn L. Anxiety and heart rate correlation prior to dental checkup. Int Dent J. 1995 Dec;45(6):347-51.

  PMID: 8666460 RESULT

• Hasse AL, Heng MK, Garrett NR. Blood pressure and electrocardiographic response to dental treatment with use of local anesthesia. J Am Dent Assoc. 1986 Oct;113(4):639-42. doi: 10.14219/jada.archive.1986.0245.

  PMID: 2945853 RESULT

• Hill CM, Mostafa P, Stuart AG, Thomas DW, Walker RV. ECG variations in patients pre- and post-local anaesthesia and analgesia. Br Dent J. 2009 Dec 19;207(12):E23. doi: 10.1038/sj.bdj.2009.978. Epub 2009 Nov 6.

  PMID: 19893562 RESULT

• 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 RESULT

• Perusse R, Goulet JP, Turcotte JY. Contraindications to vasoconstrictors in dentistry: Part I. Cardiovascular diseases. Oral Surg Oral Med Oral Pathol. 1992 Nov;74(5):679-86. doi: 10.1016/0030-4220(92)90365-w.

  PMID: 1437073 RESULT

• Rhodus NL, Falace DA. Management of the dental patient with congestive heart failure. Gen Dent. 2002 May-Jun;50(3):260-5, quiz 266-7.

  PMID: 12116514 RESULT

• Blinder D, Manor Y, Shemesh J, Taicher S. Electrocardiographic changes in cardiac patients having dental extractions under a local anesthetic containing a vasopressor. J Oral Maxillofac Surg. 1998 Dec;56(12):1399-402; discussion 1402-3. doi: 10.1016/s0278-2391(98)90403-7.

  PMID: 9846537 RESULT

• Caceres MT, Ludovice AC, Brito FS, Darrieux FC, Neves RS, Scanavacca MI, Sosa EA, Hachul DT. Effect of local anesthetics with and without vasoconstrictor agent in patients with ventricular arrhythmias. Arq Bras Cardiol. 2008 Sep;91(3):128-33, 142-7. doi: 10.1590/s0066-782x2008001500002. English, Portuguese.

  PMID: 18853053 RESULT

• 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. Circulation. 1997 Jul 1;96(1):358-66. doi: 10.1161/01.cir.96.1.358.

  PMID: 9236458 RESULT

MeSH Terms

Conditions

Heart Failure; Arrhythmias, Cardiac

Interventions

Lidocaine; Epinephrine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Itamara LI Neves, PhD

  Instituto do Coração do HCFMUSP

  PRINCIPAL INVESTIGATOR

• Edimar A Bocchi, Habilitation

  Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

  STUDY DIRECTOR

• Ricardo S Neves, PhD

  Instituto do Coração do HCFMUSP

  STUDY CHAIR

• Sergio ET Quaresma, MS.

  Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

  STUDY CHAIR

Central Study Contacts

Itamara LI Neves, PhD

CONTACT

55-11-26615229; itamara@incor.usp.br

Sergio ET Quaresma, MS

CONTACT

55-11-983890099; setquaresma@uol.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 28, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2017
• Last Updated: October 19, 2015

Record last verified: 2015-10

Locations

BR (1)