Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Local Anesthesia With Epinephrine for Oral Surgery in Type 2 Diabetes Mellitus With Corornary Disease is Safe and Effective

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173067
• Other study ID #: Odonto - Diabetes
• Status: Completed
• Phase: N/A
• First received: June 23, 2014
• Last updated: June 23, 2014
• Start date: September 2009
• Est. completion date: November 2012

Study information

• Verified date: October 2012
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Type 2 diabetes mellitus pharmacologically controlled (in use of insulin and/or hypoglycemic agents) Coronary disease -

Exclusion Criteria:

• Pregnant sepsis acute renal failure

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Brazil	Unit of Dentistry, Heart Institute	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety levels during the oral surgery with local anesthesia (lidocaine and lidocaine and epinephrine)	Anxiety levels was measurement by the Image Facial Scale at the times: one hour before the surgery, five minutes before the surgery and one hour after the surgery.	almost 3 hours
Primary	varition in blood glucose levels during oral surgery with local anaesthesia (lidocaina and lidocaine with epinephrine)	To asses the blood glucose levels the Continuous monitoring system (MiniMed CGMS, Medtronic) was employed. The MiniMed monitor was installed in the morning of the day before the surgery and the patient went to home. The patient returned to the hospital for the surgery 24 hours later and the monitor was retired one hour after the end of the oral surgery.	24 hours
Secondary	Hemodynamic effects during the surgery with local anesthetia (lidocaine and lidocaine with epinephrine)	Systolic blood pressure, diastolic blood pressur and heart rate were recorded by automatic sphygmomanometer (Microlife APA-P00001) in four times: one hour before the surgery, five minutes before the surgery, after anesthesia injection and one hour after the surgery.	almost 3 hours