Dental Anesthesia in Heart Failure Patients

Study Overview
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Brief Summary
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To investigate the occurrence of arrhythmias in dental treatment with local anesthetic.

Detailed Description
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Lidocaine with epinephrine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Safety of dental anesthesia<br>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<br>* Lidocaine without vasoconstrictor , lidocaine with epinephrine 1:100,000<br>|
| Other: Oral health profile<br>An oral health profile of patients with heart failure will be described based in oral clinical examination. | Drug: Lidocaine with epinephrine<br>* Lidocaine without vasoconstrictor , lidocaine with epinephrine 1:100,000<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental, epinephrine, local anesthetic, lidocaine, cardiac arrhythmias, procedure