Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-09 @ 2:11 PM
Study NCT ID:
NCT03252405
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2017-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Induction Method in Post Operative Agitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-30', 'studyFirstSubmitDate': '2017-08-08', 'studyFirstSubmitQcDate': '2017-08-15', 'lastUpdatePostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess changing in pediatric agitation/ emergence delirium scale(PAED) scores', 'timeFrame': 'postoperative first hour', 'description': 'to asses change of intensity of postoperative emergence agitation/ delirium (PAED) by using pediatric agitation emergence delirium scale with scores. to assess changing PAED scores at one hour after transfer into the post anesthesia care unit.'}], 'secondaryOutcomes': [{'measure': 'FLACC (face, legs,activity, cry, consolobility)', 'timeFrame': 'postoperative first hour', 'description': 'to asses postoperative pain intensity with scores by FLACC (face, legs,activity, cry, consolobility) scale after transfer into the post anesthesia care unit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emergence Agitation']}, 'referencesModule': {'references': [{'pmid': '32048203', 'type': 'DERIVED', 'citation': 'Peker K, Polat R. Effects of intravenous and mask induction on post-operative emergence delirium in pediatric patients undergoing tonsillectomy with or without adenoidectomy. Ir J Med Sci. 2020 Aug;189(3):1061-1068. doi: 10.1007/s11845-020-02197-4. Epub 2020 Feb 11.'}]}, 'descriptionModule': {'briefSummary': 'To compare the effect of two different induction method; mask ventilation and intravenous cannulation on emergence agitation on pediatric adenotonsillectomy', 'detailedDescription': 'Many things cause emergence agitation after operations on pediatric population. This research aims determine which method, mask ventilation or intravenous cannulatin is more effective on emergence agitation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric adenotonsillectomy\n\nExclusion Criteria:\n\n* patients with neurological, hepatic, renal disorders and using any drugs'}, 'identificationModule': {'nctId': 'NCT03252405', 'briefTitle': 'Effect of Induction Method in Post Operative Agitation', 'organization': {'class': 'OTHER', 'fullName': 'Ahi Evran University Education and Research Hospital'}, 'officialTitle': 'the Effect of Two Different Method; Mask Ventilation or Intravenous Canulation on Emergence Agitation and Recovery Conditions on Pediatric Adenotonsillectomy', 'orgStudyIdInfo': {'id': 'emergence agitation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'mask ventilation', 'description': 'induction is made with mask ventilation', 'interventionNames': ['Device: mask ventilation', 'Device: intravenous cannulation']}, {'type': 'EXPERIMENTAL', 'label': 'intravenous induction', 'description': 'induction is made with intravenous cannulation', 'interventionNames': ['Device: intravenous cannulation']}], 'interventions': [{'name': 'mask ventilation', 'type': 'DEVICE', 'otherNames': ['induction method with mask ventilation'], 'description': 'before intravenous induction, mask application is made. then intravenous cannulation and induction', 'armGroupLabels': ['mask ventilation']}, {'name': 'intravenous cannulation', 'type': 'DEVICE', 'otherNames': ['induction method with intravenous cannulation'], 'description': 'induction is applied by using intravenous cannulation', 'armGroupLabels': ['intravenous induction', 'mask ventilation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Dışkapı Yıldırım Beyazıt Education and research hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Kırşehir', 'country': 'Turkey (Türkiye)', 'facility': 'Ahi evran university education and research hospital', 'geoPoint': {'lat': 39.14583, 'lon': 34.16389}}], 'overallOfficials': [{'name': 'kevser peker', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ahi Evran University Education and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahi Evran University Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Kevser Peker', 'investigatorAffiliation': 'Ahi Evran University Education and Research Hospital'}}}}