Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-02-21 @ 3:45 AM
Study NCT ID:
NCT02150304
Status:
COMPLETED
Last Update Posted:
2015-08-05
First Post:
2014-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aminophylline Prophylaxis For Postdural Puncture Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051299', 'term': 'Post-Dural Puncture Headache'}], 'ancestors': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-04', 'studyFirstSubmitDate': '2014-05-24', 'studyFirstSubmitQcDate': '2014-05-26', 'lastUpdatePostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postdural puncture headache', 'timeFrame': 'postoperative 2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postdural Puncture Headache']}, 'referencesModule': {'references': [{'pmid': '24600595', 'type': 'BACKGROUND', 'citation': 'Naghibi K, Hamidi M. Prophylactic administration of aminophylline plus dexamethasone reduces post-dural puncture headache better than using either drug alone in patients undergoing lower extremity surgery. Adv Biomed Res. 2014 Jan 9;3:5. doi: 10.4103/2277-9175.124631. eCollection 2014.'}, {'pmid': '23450533', 'type': 'BACKGROUND', 'citation': 'Basurto Ona X, Uriona Tuma SM, Martinez Garcia L, Sola I, Bonfill Cosp X. Drug therapy for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD001792. doi: 10.1002/14651858.CD001792.pub3.'}]}, 'descriptionModule': {'briefSummary': 'postdural puncture headache is a rare but serious complication of spinal anesthesia. many drugs were studied in prevention or treatment of that complication. However, there are limited numbers of trials about intravenous aminophylline for prevention. because of that we retrospectively aimed to investigate the effectiveness of aminophylline for postdural puncture headache in cesarean section.', 'detailedDescription': 'retrospective trial about the effect of intravenous aminophylline for prevention of PDPH after caserean section with spinal anesthesia'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patient records form who experinced headache after caserean section with spinal anesthesia were retrospectively evaluated', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aolder than 18 years old\n\nExclusion Criteria:\n\n* conversion to general anesthesia'}, 'identificationModule': {'nctId': 'NCT02150304', 'briefTitle': 'Aminophylline Prophylaxis For Postdural Puncture Headache', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Diskapi Yildirim Beyazit Education and Research Hospital'}, 'officialTitle': 'Phase IV Study of Intravenous Aminophylline During Spinal Anesthesia', 'orgStudyIdInfo': {'id': 'PDPHAMINOPHYLLINE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'intravenous aminophylline', 'description': 'intravenous aminophylline use during spinal anesthesia'}, {'label': 'no intravenous aminophylline', 'description': 'no use of intravenous aminophylline during spinal anesthesia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06110', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Dışkapı Yıldırım Beyazıt Education and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'ibrahim öztürk, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'dışkapı yıldırım beyazıt education and research hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Yildirim Beyazit Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'İBRAHİM ÖZTÜRK', 'investigatorAffiliation': 'Diskapi Yildirim Beyazit Education and Research Hospital'}}}}