Anesthesia for Dental Treatment in Cardiac Patients: Lidocaine Comparative Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-07-31

Brief Summary

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Prospective, randomized double-blinded study to investigate hemodynamic changes in valvular cardiac patients during dental treatment with the use of a local anesthesia containing epinephrine.

Detailed Description

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Patients with valvular disease constitute a group in which local anesthesia must be effective to avoid higher release of endogenous catecholamines that could trigger hemodynamic. The study was conducted in the Dental Department of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (Brazil). Patients were allocated into two groups through an aleatory numbered table: PL (plain 2% lidocaine, n= 31) and LE (2% lidocaine with 1:100.000 epinephrine, n= 28). The anesthetic amount was registered. DIXTAL monitor (São Paulo- Brazil) captured blood pressure, heart rate, oxygenation and electrocardiogram records.

Conditions

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Arrhythmias Anxiety

Keywords

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Anesthesia, Local Lidocaine Dental care Arrhythmias, Cardiac Anxiety

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PL

Patients who receive local anesthesia with 2% lidocaine without epinephrine

No interventions assigned to this group

LE

Patients who receive local anesthesia with 2% lidocaine with 1:100.000 epinephrine

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with acquired valvular disease

Exclusion Criteria

* Patients having platelets counting lower than 70.000 or INR \> 3

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Divisão de Anestesia, Hospital das Clínicas da FMUSP

Principal Investigators

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Joaquim E Vieira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo Medical School - FMUSP

Locations

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Hospital das Clínicas da FMUSP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CAP432-03

Identifier Type: -

Identifier Source: org_study_id