Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:42 PM
Study NCT ID:
NCT02173067
Status:
COMPLETED
Last Update Posted:
2014-06-24
First Post:
2014-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective
Sponsor:
University of Sao Paulo General Hospital
Organization:
Study Overview
Official Title:
Local Anesthesia With Epinephrine for Oral Surgery in Type 2 Diabetes Mellitus With Corornary Disease is Safe and Effective
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: