Heart Failure
Conditions
Keywords
dental, epinephrine, local anesthetic, lidocaine, cardiac arrhythmias, procedure
Brief summary
To investigate the occurrence of arrhythmias in dental treatment with local anesthetic.
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.
Interventions
Lidocaine without vasoconstrictor , lidocaine with epinephrine 1:100,000
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate (bpm) | 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. |
Countries
Brazil
Contacts
Primary ContactItamara LI Neves, PhD
Backup ContactSergio ET Quaresma, MS
Outcome results
None listed