Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-03-05 @ 4:54 PM
Study NCT ID:
NCT02735018
Status:
COMPLETED
Last Update Posted:
2016-04-12
First Post:
2016-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Cardiovascular Effects of 1:100,000 and 1:200,000 Epinephrine Solutions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-11-28', 'releaseDate': '2016-10-06'}, {'resetDate': '2018-05-11', 'releaseDate': '2018-04-11'}, {'resetDate': '2018-07-11', 'releaseDate': '2018-06-13'}, {'resetDate': '2018-09-12', 'releaseDate': '2018-08-15'}, {'resetDate': '2018-10-25', 'releaseDate': '2018-09-26'}], 'estimatedResultsFirstSubmitDate': '2016-10-06'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-06', 'studyFirstSubmitDate': '2016-03-18', 'studyFirstSubmitQcDate': '2016-04-06', 'lastUpdatePostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': '20 minutes'}, {'measure': 'Blood pressure', 'timeFrame': '20 minutes'}, {'measure': 'Arterial oxygen saturation, measured with a pulse oximeter device', 'timeFrame': '20 minutes'}, {'measure': 'Bleeding, evaluated by the surgeon as either: 1) normal or 2) excessive', 'timeFrame': '20 minutes'}, {'measure': 'Pain, evaluated using a visual analogue scale', 'timeFrame': 'After procedure, about 1 hour'}]}, 'conditionsModule': {'conditions': ['Cardiovascular Response to Epinephrine']}, 'descriptionModule': {'briefSummary': 'The study aim to evaluate systemic response of patients when 2 different concentrations of Epinephrine are injected during inferior alveolar nerve block for wisdom teeth extraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Class I patients according to the American Society of Anesthesiology (ASA),\n* Indication for third molars extraction,\n* Similar degree of complexity, according to the classification of Pell and Gregory.\n\nExclusion Criteria:\n\n* Patients with systemic conditions,\n* Patients with known allergy to any component of the anesthetic solution.'}, 'identificationModule': {'nctId': 'NCT02735018', 'briefTitle': 'Comparing Cardiovascular Effects of 1:100,000 and 1:200,000 Epinephrine Solutions', 'organization': {'class': 'OTHER', 'fullName': 'Rio de Janeiro State University'}, 'officialTitle': 'Randomized Double-blind Clinical Trial Comparing the Cardiovascular Effects of Local Anesthesia Solutions Containing 1:100,000 and 1:200,000 of Epinephrine Concentrations', 'orgStudyIdInfo': {'id': '496.117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epinephrine 1:100,000', 'description': 'Inferior alveolar nerve block with Epinephrine 1:100.000', 'interventionNames': ['Drug: Epinephrine 1:100,000']}, {'type': 'EXPERIMENTAL', 'label': 'Epinephrine 1:200,000', 'description': 'Inferior alveolar nerve block with Epinephrine 1:200.000', 'interventionNames': ['Drug: Epinephrine 1:200,000']}], 'interventions': [{'name': 'Epinephrine 1:100,000', 'type': 'DRUG', 'description': 'Inferior alveolar nerve block with Epinephrine 1:100.000', 'armGroupLabels': ['Epinephrine 1:100,000']}, {'name': 'Epinephrine 1:200,000', 'type': 'DRUG', 'description': 'Inferior alveolar nerve block with Epinephrine 1:200.000', 'armGroupLabels': ['Epinephrine 1:200,000']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rio de Janeiro State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, MD, MS, PhD, Program Director', 'investigatorFullName': 'Fabio Ritto', 'investigatorAffiliation': 'Rio de Janeiro State University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-10-06', 'type': 'RELEASE'}, {'date': '2016-11-28', 'type': 'RESET'}, {'date': '2018-04-11', 'type': 'RELEASE'}, {'date': '2018-05-11', 'type': 'RESET'}, {'date': '2018-06-13', 'type': 'RELEASE'}, {'date': '2018-07-11', 'type': 'RESET'}, {'date': '2018-08-15', 'type': 'RELEASE'}, {'date': '2018-09-12', 'type': 'RESET'}, {'date': '2018-09-26', 'type': 'RELEASE'}, {'date': '2018-10-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Fabio Ritto, DDS, MD, MS, PhD, Program Director, Rio de Janeiro State University'}}}}