Dental Anesthesia in Heart Failure Patients

Heart Failure Clinical Trial

— DAHFP  

Official title:

Occurrence of Heart Arrhythmia During Restorative Dental Procedure Under Local Anesthesia , in Heart Failure Pacients. A Double-blind Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02228083
• Other study ID #: InsufCard
• Status: Recruiting
• Phase: N/A
• First received: August 26, 2014
• Last updated: October 15, 2015
• Start date: September 2014
• Est. completion date: September 2017

Study information

• Verified date: October 2015
• Source: University of Sao Paulo General Hospital
• Contact: Itamara LI Neves, PhD
• Phone: 55-11-26615229
• Email: itamara[@]incor.usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Brazil	Instituto do Coração HCFMUSP	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (17)

[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. — View Citation

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. — View Citation

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. — View Citation

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. Engli — View Citation

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 As — View Citation

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. — View Citation

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 S — View Citation

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. — View Citation

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 — View Citation

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, Sm — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes