Dental Anesthesia in Heart Failure Patients (DAHFP)

October 15, 2015 updated by: University of Sao Paulo General Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403000
        • Recruiting
        • Instituto do Coração HCFMUSP
        • Contact:
        • Contact:
        • Principal Investigator:
          • Itamara LI Neves, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

August 26, 2014

First Submitted That Met QC Criteria

August 27, 2014

First Posted (Estimate)

August 28, 2014

Study Record Updates

Last Update Posted (Estimate)

October 19, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InsufCard

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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