Trials / Completed
CompletedNCT02173067
Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective
Local Anesthesia With Epinephrine for Oral Surgery in Type 2 Diabetes Mellitus With Corornary Disease is Safe and Effective
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 70 (actual)
- Sponsor
- University of Sao Paulo General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate the variation in blood glucose levels, hemodynamic effects and patient anxiety score during tooth extraction in type 2 diabetes mellitus with coronary disease patient under local anesthesia with lidocaine 2% with and without epinephrine.
Detailed description
This is a prospective randomized study including 70 diabetes with coronary disease patients that needed to be submitted to oral surgery. The study was double blind in relation to glycaemia measurements. Continuous monitoring of blood glucose levels for 24 hours was performed using the Minimed Continuous Monitoring System (CGMS, Medtronic). Patientes were randomized into two groups: 35 received 5.4 mL of 2% lidocaine and 35 received 5.4 mL of 2% lidocaine with 1:100,000 epinephrine. In addittion, hemodynamic effects (blood pressure and heart rate) and degree of anxiety were also evaluated.
Conditions
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2012-11-01
- Completion
- 2012-11-01
- First posted
- 2014-06-24
- Last updated
- 2014-06-24
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT02173067. Inclusion in this directory is not an endorsement.