Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2025-12-28 @ 1:00 PM
Study NCT ID:
NCT01032161
Status:
COMPLETED
Last Update Posted:
2013-02-26
First Post:
2009-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Risk Factors for Postoperative Delirium in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-24', 'studyFirstSubmitDate': '2009-12-14', 'studyFirstSubmitQcDate': '2009-12-14', 'lastUpdatePostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The presence of delirium in post anesthesia care unit (PACU) and in ward determined by RASS-PAEDS criteria', 'timeFrame': 'at 1, 8, 16, 24, 48 and 72 postoperative hour'}], 'secondaryOutcomes': [{'measure': 'Maximal and minimal heart rate in PACU', 'timeFrame': 'every 15 min during PACU stay'}, {'measure': 'Pulse Oximeter Oxygen Saturation (SpO2) in PACU', 'timeFrame': 'every 15 min during PACU stay'}, {'measure': 'Hospital-length of stay', 'timeFrame': 'before discharge'}, {'measure': 'Total health care fees', 'timeFrame': 'during hospital stay'}, {'measure': 'Quality of recovery measured by PACBIS criteria', 'timeFrame': 'at 1, 8, 16, 24, 48 and 72 postoperative hour'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Delirium', 'Postoperative', 'Non-cardiovascular surgery', 'Post-anaesthesia care unit', 'patients between 3 to 12 years old', 'undergoing selective non-cardiac surgery', 'under general anesthesia', 'surgery', 'general anesthesia'], 'conditions': ['Delirium, Postoperative']}, 'descriptionModule': {'briefSummary': 'Despite recent advances in postoperative delirium research, the proportion of children with postoperative delirium is still high. Although postoperative delirium is a frequent complication and is associated with the need for more inpatient hospital care and longer length of hospital stay, little is known about risk factors for recovery room delirium (RRD) occurred in postanaesthesia care unit. The aim of the study was to determine pre- and intraoperative risk factors for the development of RRD among children undergoing non cardiovascular surgery.', 'detailedDescription': 'Recovery room delirium (RRD) defined as delirium occurred in PACU was diagnosed according to RASS-PAEDS criteria. Pre-, intra-, and postoperative data of patients undergoing elective non cardiovascular surgery were prospectively collected, univariate and multivariate logistic regression were performed to find the risk factors related to postoperative delirium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients between 3 to 12 years old, who were admitted to the PACU after elective non-cardiac surgery under general anaesthesia during regular working hours (9:00Am to 5:00Pm)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between 3 to 12 years old\n* elective non-cardiovascular surgery\n* general anesthesia\n\nExclusion Criteria:\n\n* under regional anaesthesia\n* instable vital sign\n* without consent form\n* underwent neurosurgery\n* history of primary neurologic diseases\n* stayed less than 10min in PACU\n* received general anaesthesia but recovered in locations outside the recovery room'}, 'identificationModule': {'nctId': 'NCT01032161', 'briefTitle': 'Perioperative Risk Factors for Postoperative Delirium in Children', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Perioperative Risk Factors for Postoperative Delirium in Children Following General Anesthesia', 'orgStudyIdInfo': {'id': 'TIHMZK02002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Delirium', 'description': 'Delirium was determined by RASS-PAEDS'}, {'label': 'no Delirium', 'description': 'no Delirium was determined by RASS-PAEDS'}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Chuanhan Zhang, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, {'name': 'Yuke Tian, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Wei Mei', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}