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Anesthesia for Dental Treatment in Cardiac Patients: Lidocaine Comparative Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00669838
First Posted: May 1, 2008
Last Update Posted: May 1, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
  Purpose
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.

Condition
Arrhythmias Anxiety

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Loco Regional Anesthesia for Dental Treatment in Cardiac Patients: Comparative Study Between Plain Lidocaine 2% and Lidocaine 2% With Epinephrine 1:100.000

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • arrhythmias [ Time Frame: during procedure ]

Secondary Outcome Measures:
  • Arterial pressure [ Time Frame: during procedure ]
  • anxiety [ Time Frame: during and imediately after procedure ]

Enrollment: 59
Study Start Date: January 2003
Study Completion Date: July 2005
Groups/Cohorts
PL
Patients who receive local anesthesia with 2% lidocaine without epinephrine
LE
Patients who receive local anesthesia with 2% lidocaine with 1:100.000 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acquired valvular diseases participated in this study, aging between 18-65 years in need of dental surgery (extractions) or restorative dentistry in mandible
Criteria

Inclusion Criteria:

  • Patients with acquired valvular disease

Exclusion Criteria:

  • Patients having platelets counting lower than 70.000 or INR > 3
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669838


Locations
Brazil
Hospital das Clínicas da FMUSP
Sao Paulo, Brazil, 05430 010
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Joaquim E Vieira, MD, PhD University of Sao Paulo Medical School - FMUSP
  More Information

Responsible Party: Joaquim Edson Vieira, Divisão de Anestesia, Hospital das Clínicas da FMUSP
ClinicalTrials.gov Identifier: NCT00669838     History of Changes
Other Study ID Numbers: CAP432-03
First Submitted: April 29, 2008
First Posted: May 1, 2008
Last Update Posted: May 1, 2008
Last Verified: April 2008

Keywords provided by University of Sao Paulo:
Anesthesia, Local
Lidocaine
Dental care
Arrhythmias, Cardiac
Anxiety

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Epinephrine
Racepinephrine
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents