Clinical trial NCT02228083: Dental Anesthesia in Heart Failure Patients
Official title: Occurrence of Heart Arrhythmia During Restorative Dental Procedure Under Local Anesthesia , in Heart Failure Pacients. A Double-blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: dental
epinephrine
local anesthetic
lidocaine
cardiac arrhythmias
procedure
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-08-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Heart rate (bpm)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração HCFMUSP
Study officials:
affiliation: Instituto do Coração do HCFMUSP
name: Itamara LI Neves, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
name: Edimar A Bocchi, Habilitation
role: STUDY_DIRECTOR
affiliation: Instituto do Coração do HCFMUSP
name: Ricardo S Neves, PhD
role: STUDY_CHAIR
affiliation: Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
name: Sergio ET Quaresma, MS.
role: STUDY_CHAIR
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