Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-02-05 @ 11:59 PM
Study NCT ID:
NCT02173067
Status:
COMPLETED
Last Update Posted:
2014-06-24
First Post:
2014-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-11-03', 'releaseDate': '2017-06-20'}, {'resetDate': '2021-11-02', 'releaseDate': '2021-10-05'}, {'resetDate': '2022-10-27', 'releaseDate': '2022-04-04'}], 'estimatedResultsFirstSubmitDate': '2017-06-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Type 2 diabete mellitus (in use of insulin and/or hypoglicemic agents) with coronary disease adults patients who needes to have at least one posterior maxillary tooth extracted, according to oral examination and panoramic radiography.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-23', 'studyFirstSubmitDate': '2014-06-23', 'studyFirstSubmitQcDate': '2014-06-23', 'lastUpdatePostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Anxiety levels during the oral surgery with local anesthesia (lidocaine and lidocaine and epinephrine)', 'timeFrame': 'almost 3 hours', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'varition in blood glucose levels during oral surgery with local anaesthesia (lidocaina and lidocaine with epinephrine)', 'timeFrame': '24 hours', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Hemodynamic effects during the surgery with local anesthetia (lidocaine and lidocaine with epinephrine)', 'timeFrame': 'almost 3 hours', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes mellitus', 'Epinephrine', 'Anesthesia, Dental', 'lidocaine', 'Ambulatory Surgical Procedures'], 'conditions': ['Type 2 Diabetes Mellitus', 'Coronary Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nType 2 diabetes mellitus pharmacologically controlled (in use of insulin and/or hypoglycemic agents) Coronary disease -\n\nExclusion Criteria:\n\n* Pregnant sepsis acute renal failure'}, 'identificationModule': {'nctId': 'NCT02173067', 'briefTitle': 'Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Local Anesthesia With Epinephrine for Oral Surgery in Type 2 Diabetes Mellitus With Corornary Disease is Safe and Effective', 'orgStudyIdInfo': {'id': 'Odonto - Diabetes'}}, 'armsInterventionsModule': {'armGroups': [{'label': '2% lidocaine', 'description': '35 patients received 5.4 mL of 2% lidocaine.'}, {'label': '2% lidocaine with epinephrine', 'description': '35 patients recieved 5.4 mL of 2% lidocaine with 1:100,000 epinephrine.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Unit of Dentistry, Heart Institute', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Marcela A Santos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-06-20', 'type': 'RELEASE'}, {'date': '2017-11-03', 'type': 'RESET'}, {'date': '2021-10-05', 'type': 'RELEASE'}, {'date': '2021-11-02', 'type': 'RESET'}, {'date': '2022-04-04', 'type': 'RELEASE'}, {'date': '2022-10-27', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Sao Paulo General Hospital'}}}}