Anesthesia for Dental Treatment in Cardiac Patients: Lidocaine Comparative Study

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00669838
First received: April 29, 2008
Last updated: April 30, 2008
Last verified: April 2008
  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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Arterial pressure [ Time Frame: during procedure ] [ Designated as safety issue: Yes ]
  • anxiety [ Time Frame: during and imediately after procedure ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 29, 2008
Last Updated: April 30, 2008
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014