Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT05567718
Status:
COMPLETED
Last Update Posted:
2022-10-05
First Post:
2022-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Relationship Between Fasting Time and Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-03', 'studyFirstSubmitDate': '2022-10-03', 'studyFirstSubmitQcDate': '2022-10-03', 'lastUpdatePostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pediatric Anesthesia Emergence Delirium scale', 'timeFrame': 'during the procedure', 'description': 'to measure delirium using the scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emergence delirium', 'pediatric', 'preoperative fasting', 'magnetic resonance imaging'], 'conditions': ['Delirium', 'Sedation Complication', 'Magnetic Resonance Imaging', 'Fasting']}, 'descriptionModule': {'briefSummary': 'We investigated the relationship between fasting times and delirium in children undergoing MRI under anesthesia. Paediatric Anaesthesia Emergence Delirium (PAED) scale, last oral intake time and type of food (solid-liquid) and fasting time, laryngospasm, desaturation (SpO2 \\<95%), bradycardia, allergy, nausea and vomiting were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'children between the age group 2-6 years of American Society of Anesthesiologists (ASA) physical status I or II, patients undergoing MRI under sedation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children between the age group 2-6 years of American Society of Anesthesiologists (ASA) physical status I or II\n* Patients undergoing MRI under sedation\n\nExclusion Criteria:\n\n* ASA 3-4-5\n* under 2 years old, over 6 years old\n* cognitive or psychological disorder\n* serious central nervous system diseases, including a brain tumor or uncontrolled seizures\n* type 1 diabetes\n* detection of ≤ 50 mg/dl in fasting blood glucose measurement\n* whose parents did not want to participate in the study'}, 'identificationModule': {'nctId': 'NCT05567718', 'briefTitle': 'The Relationship Between Fasting Time and Delirium', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, 'officialTitle': 'The Relationship Between Fasting Time and Emergency Delirium in Pediatric Sedation Undergoing Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': '2011-KAEK-25 2021/12/07'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Paediatric Anaesthesia Emergence Delirium scale', 'type': 'BEHAVIORAL', 'description': 'measure emergence delirium in children'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16600', 'city': 'Yıldırım', 'state': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Bursa Yüksek Ihtisas Training and Research Hospital', 'geoPoint': {'lat': 40.32939, 'lon': 29.55811}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Yuksek Ihtisas Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor', 'investigatorFullName': 'Ayse Neslihan Balkaya', 'investigatorAffiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}}}}