Anesthesia for Dental Treatment in Cardiac Patients: Lidocaine Comparative Study

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669838
• Other study ID #: CAP432-03
• Status: Completed
• Phase: N/A
• First received: April 29, 2008
• Last updated: April 30, 2008
• Start date: January 2003
• Est. completion date: July 2005

Study information

• Verified date: April 2008
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with acquired valvular disease

Exclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety
• Arrhythmias

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da FMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arrhythmias		during procedure	Yes
Secondary	Arterial pressure		during procedure	Yes
Secondary	anxiety		during and imediately after procedure	Yes