Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective

NCT ID: NCT02173067

Last Updated: 2014-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-11-30

Brief Summary

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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

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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

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Type 2 Diabetes Mellitus Coronary Disease

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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2% lidocaine

35 patients received 5.4 mL of 2% lidocaine.

No interventions assigned to this group

2% lidocaine with epinephrine

35 patients recieved 5.4 mL of 2% lidocaine with 1:100,000 epinephrine.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcela A Santos, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Unit of Dentistry, Heart Institute

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Odonto - Diabetes

Identifier Type: -

Identifier Source: org_study_id

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