Dental Anesthesia in Heart Failure Patients (DAHFP)

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ClinicalTrials.gov Identifier: NCT02228083

Recruitment Status : Unknown

Verified October 2015 by University of Sao Paulo General Hospital.
Recruitment status was: Recruiting

First Posted : August 28, 2014

Last Update Posted : October 19, 2015

Sponsor:

Collaborator:

Fundação de Amparo à Pesquisa do Estado de São Paulo

Information provided by (Responsible Party):

University of Sao Paulo General Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Heart Failure	Drug: Lidocaine with epinephrine	Not Applicable

Detailed Description:

Heart failure is defined as the inability of the heart to offer blood supply required to meet metabolic demand of the tissues and thus exercise adequately its role as a pump. According to data collected from the single health system (DATASUS), approximately 6.4 million Brazilians have heart failure. This large contingent of patients will require multi-professional treatment, in particular, careful with dental health heart failure is regarded as the final common pathway of most cardiovascular diseases and, after installation of symptoms (mainly in the stages of functional class NYHA III and IV) have poor prognosis with average survival of 1.7 years 3.2 years for men and for women. Dental treatment often requires application of local anesthetic. The adrenaline, agent vasoconstrictor, is widely used in dental treatment and aims to extend the effect of local anesthetic. Specifically in people with heart failure, there shortcomings of evidence in the literature, the harmful effects of adrenaline 1:100,000 added to the local anaesthetic lidocaine. Among the potential complications, we can highlight: arrhythmias, systemic blood pressure elevation and elevation of heart rate. The main objective of this work will investigate the occurrence of arrhythmias by evaluating of electrocardiographic parameters. Our secondary objectives will be assessing: variations of blood pressure by ambulatory blood pressure monitoring, cardiac frequency and chest pain. We will study 70 patients between 18 and 75 years with a diagnosis of congestive heart failure functional class NYHA III and IV and restorative dental treatment indication. A random picture in double-blind study, patients are divided into two groups, one group receives as local anesthetic lidocaine 2% with adrenaline 1 in comparison with the second group that will receive 2% lidocaine with vasoconstrictor.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	70 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Occurrence of Heart Arrhythmia During Restorative Dental Procedure Under Local Anesthesia , in Heart Failure Pacients. A Double-blind Study
Study Start Date :	September 2014
Estimated Primary Completion Date :	September 2016
Estimated Study Completion Date :	September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health Heart Failure

Drug Information available for: Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Lidocaine hydrochloride Lidocaine Racepinephrine hydrochloride Racepinephrine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Safety of dental anesthesia 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 Lidocaine without vasoconstrictor , lidocaine with epinephrine 1:100,000
Oral health profile An oral health profile of patients with heart failure will be described based in oral clinical examination.	Drug: Lidocaine with epinephrine Lidocaine without vasoconstrictor , lidocaine with epinephrine 1:100,000

Outcome Measures

Primary Outcome Measures :

Heart rate (bpm) [ Time Frame: 24 hours ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228083

Contacts

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Contact: Itamara LI Neves, PhD	55-11-26615229	itamara@incor.usp.br
Contact: Sergio ET Quaresma, MS	55-11-983890099	setquaresma@uol.com.br

Locations

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Brazil
Instituto do Coração HCFMUSP	Recruiting
São Paulo, Brazil, 05403000
Contact: Itamara LI Neves, PhD 1126615229 itamara@incor.usp.br
Contact: Sergio ET Quaresma, MS. 11983890099 setquaresma@uol.com.br
Principal Investigator: Itamara LI Neves, PhD

Sponsors and Collaborators

University of Sao Paulo General Hospital

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

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Principal Investigator:	Itamara LI Neves, PhD	Instituto do Coração do HCFMUSP
Study Director:	Edimar A Bocchi, Habilitation	Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study Chair:	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

More Information

Publications of Results:

[Guidelines of the Brazilian Cardiology Society to the diagnosis and treatment of heart failure]. Arq Bras Cardiol. 1999 Feb;72 Suppl 1:1-30. Portuguese.

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. Epub 2005 Sep 13.

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.

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.

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.

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. Erratum in: J Am Dent Assoc 1986 Dec;113(6):868.

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.

Neves RS, Neves IL, Giorgi DM, Grupi CJ, César 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. English, Portuguese.

Pérusse 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. Review.

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.

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.

Cáceres 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. English, Portuguese.

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. Review.

Other Publications:

Mann DL. Mechanisms and models in heart failure: A combinatorial approach. Circulation. 1999 Aug 31;100(9):999-1008. Review.

Palatini P, Frigo G, Bertolo O, Roman E, Da Cortà 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.

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.

SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35.

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Responsible Party:	University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:	NCT02228083
Other Study ID Numbers:	InsufCard
First Posted:	August 28, 2014 Key Record Dates
Last Update Posted:	October 19, 2015
Last Verified:	October 2015

Keywords provided by University of Sao Paulo General Hospital:


dental epinephrine local anesthetic	lidocaine cardiac arrhythmias procedure

Additional relevant MeSH terms:

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Heart Failure Heart Diseases Cardiovascular Diseases Lidocaine Epinephrine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers	Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics Vasoconstrictor Agents

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