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Completed

NCT Number: NCT00669838

Anesthesia for Dental Treatment in Cardiac Patients: Lidocaine Comparative Study

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.

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Key information

Conditions

Arrhythmias Anxiety Anxiety Disorders Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital das Clínicas da FMUSP

São Paulo, 05430 010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with acquired valvular disease

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. arrhythmias

    Time frame: during procedure

Secondary outcomes

  1. Arterial pressure

    Time frame: during procedure

  2. anxiety

    Time frame: during and imediately after procedure

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Loco Regional Anesthesia for Dental Treatment in Cardiac Patients: Comparative Study Between Plain Lidocaine 2% and Lidocaine 2% With Epinephrine 1:100.000

Important dates

Study start
2003
Study completion
2005
First posted
May 1, 2008
Registry last updated
May 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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