Type 2 Diabetes MellitusNCT02173067
Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective
An observational study of Type 2 Diabetes Mellitus and Coronary Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Coronary Disease
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2009to Nov 2012
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We enrolled pharmacologically controlled type 2 diabetes mellitus (in use of insulin and/or hypoglycemic agents) and with coronary disease adult patient who needed to have at least one posterior maxillary tooth to be extracted.
Who may be able to join
- Type 2 diabetes mellitus pharmacologically controlled (in use of insulin and/or hypoglycemic agents) Coronary disease -
Who cannot join
- Pregnant sepsis acute renal failure
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Unit of Dentistry, Heart Institute
São Paulo, São Paulo, 05403-900
About this study
Official title: Local Anesthesia With Epinephrine for Oral Surgery in Type 2 Diabetes Mellitus With Corornary Disease is Safe and Effective
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.
Read the 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
- Type 2 Diabetes Mellitus, Coronary Disease
- Keywords
- Diabetes mellitus, Epinephrine, Anesthesia, Dental, lidocaine, Ambulatory Surgical Procedures
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 2% lidocaine | 35 patients received 5.4 mL of 2% lidocaine. | |
| 2% lidocaine with epinephrine | 35 patients recieved 5.4 mL of 2% lidocaine with 1:100,000 epinephrine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (1)
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.
Measured: almost 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startSep 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Marcela A Santos, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173067
- Sponsor's protocol ID
- Odonto - Diabetes
- Status last verified
- Oct 2012
- First submitted
- 23 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Anesthesia With Epinephrine for Oral Surgery in Type 2 Diabetes Mellitus With Corornary Disease is Safe and Effective
- ClinicalTrials.gov ID
- NCT02173067
- Acronym / sponsor ID
- Odonto - Diabetes
- Conditions
- Type 2 Diabetes Mellitus, Coronary Disease
- Keywords
- Diabetes mellitus, Epinephrine, Anesthesia, Dental, lidocaine, Ambulatory Surgical Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Sep 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2% lidocaine | – | –35 patients received 5.4 mL of 2% lidocaine. |
| 2% lidocaine with epinephrine | – | –35 patients recieved 5.4 mL of 2% lidocaine with 1:100,000 epinephrine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We enrolled pharmacologically controlled type 2 diabetes mellitus (in use of insulin and/or hypoglycemic agents) and with coronary disease adult patient who needed to have at least one posterior maxillary tooth to be extracted.
Key inclusion criteria (1 listed)
- Type 2 diabetes mellitus pharmacologically controlled (in use of insulin and/or hypoglycemic agents) Coronary disease -
Key exclusion criteria (1 listed)
- Pregnant sepsis acute renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
varition in blood glucose levels during oral surgery with local anaesthesia (lidocaina and lidocaine with epinephrine)
Time frame: 24 hours
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.
1 secondary outcome
Hemodynamic effects during the surgery with local anesthetia (lidocaine and lidocaine with epinephrine)
Time frame: almost 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcela A Santos, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Coronary Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
varition in blood glucose levels during oral surgery with local anaesthesia (lidocaina and lidocaine with epinephrine) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2014.