Anesthesia for Dental Treatment in Cardiac Patients: Lidocaine Comparative Study

Completed

• Conditions: Arrhythmias; Anxiety

• Registration Number: NCT00669838
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-01
• Study Completion: 2005-07
• Status Verified: 2008-04
• Study First Submitted: 2008-04-29
• Study First Submitted QC: 2008-04-30
• Last Update Submitted: 2008-04-30
• Study First Posted: 2008-05-01
• Last Update Posted: 2008-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Patients with acquired valvular disease

Exclusion Criteria

• Patients having platelets counting lower than 70.000 or INR > 3

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
arrhythmias	during procedure

Secondary Outcome Measures

Name	Time	Method
Arterial pressure	during procedure
anxiety	during and imediately after procedure

Trial Locations

Locations (1)

Hospital das Clínicas da FMUSP; 🇧🇷 Sao Paulo, Brazil