Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-30 @ 8:30 PM
Study NCT ID:
NCT04219033
Status:
UNKNOWN
Last Update Posted:
2022-10-18
First Post:
2019-12-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Cognitive Function and EEG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-15', 'studyFirstSubmitDate': '2019-12-31', 'studyFirstSubmitQcDate': '2020-01-02', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference of delta wave miss rate between patients with or without cognitive dysfunction by 1 day after surgery', 'timeFrame': 'from end of surgery to 1 day after surgery', 'description': 'The difference (OR) between the miss rate of delta wave in patients with and without cognitive function change 1 day after operation.'}, {'measure': 'The difference of spindle miss rate between patients with or without cognitive dysfunction by 1day after surgery', 'timeFrame': 'from end of surgery to 1 day after surgery', 'description': 'The difference (OR) between the miss rate of spindle in patients with and without cognitive function change 1 day after operation.'}], 'secondaryOutcomes': [{'measure': 'The difference of delta wave miss rate between patients with or without cognitive dysfunction by 3 days after surgery', 'timeFrame': 'from end of surgery to 3 day after surgery'}, {'measure': 'The difference of spindle miss rate between patients with or without cognitive dysfunction by 3 days after surgery', 'timeFrame': 'from end of surgery to 3 days after surgery'}, {'measure': 'The difference of burst suppression rate between patients with or without cognitive dysfunction by 3 days after surgery', 'timeFrame': 'from end of surgery to 3 days after surgery'}, {'measure': 'correlation of delta wave miss rate and incidence of postoperative cognitive dysfunction by 1 day after surgery', 'timeFrame': 'from end of surgery to 1 day after surgery'}, {'measure': 'correlation of delta wave miss rate and incidence of postoperative cognitive dysfunction by 3 days after surgery', 'timeFrame': 'from end of surgery to 3 days after surgery'}, {'measure': 'correlation of spindle miss rate and incidence of postoperative cognitive dysfunction by 1d after surgery', 'timeFrame': 'from end of surgery to 1d after surgery'}, {'measure': 'correlation of spindle miss rate and incidence of postoperative cognitive dysfunction by 3 days after surgery', 'timeFrame': 'from end of surgery to 3 days after surgery'}, {'measure': 'correlation of burst suppression rate and incidence of postoperative cognitive dysfunction by 1 day after surgery', 'timeFrame': 'from end of surgery to 1 day after surgery'}, {'measure': 'correlation of burst suppression rate and incidence of postoperative cognitive dysfunction by 3 days after surgery', 'timeFrame': 'from end of surgery to 3 days after surgery'}, {'measure': 'correlation of burst suppression rate and incidence of death by 30 days after surgery', 'timeFrame': 'from end of surgery to 30 days after surgery'}, {'measure': 'correlation of delta wave miss rate and incidence of death by 30 days after surgery', 'timeFrame': 'from end of surgery to 30 days after surgery'}, {'measure': 'correlation of spindle miss rate and incidence of death by 30 days after surgery', 'timeFrame': 'from end of surgery to 30 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['noncardiac surgery', 'elderly patients', 'postoperative cognitive dysfunction', 'Electroencephalogram'], 'conditions': ['Aging', 'Postoperative Cognitive Dysfunction', 'EEG With Periodic Abnormalities']}, 'referencesModule': {'references': [{'pmid': '27752068', 'type': 'RESULT', 'citation': 'Vutskits L, Xie Z. Lasting impact of general anaesthesia on the brain: mechanisms and relevance. Nat Rev Neurosci. 2016 Oct 18;17(11):705-717. doi: 10.1038/nrn.2016.128.'}, {'pmid': '18156878', 'type': 'RESULT', 'citation': 'Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.'}, {'pmid': '11065205', 'type': 'RESULT', 'citation': 'Abildstrom H, Rasmussen LS, Rentowl P, Hanning CD, Rasmussen H, Kristensen PA, Moller JT. Cognitive dysfunction 1-2 years after non-cardiac surgery in the elderly. ISPOCD group. International Study of Post-Operative Cognitive Dysfunction. Acta Anaesthesiol Scand. 2000 Nov;44(10):1246-51. doi: 10.1034/j.1399-6576.2000.441010.x.'}]}, 'descriptionModule': {'briefSummary': 'In the elderly patients undergoing elective non-cardiac major surgery, the differences of EEG parameters between those with and without postoperative cognitive dysfunction were observed to determine the characteristic changes of EEG parameters related to postoperative cognitive dysfunction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1150 cases in the elderly group and 100 cases in the adult background group', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged 65 and above\n2. non-cardiac surgery under general anesthesia;\n3. American Society of Anesthesiology(ASA) classification I- II\n4. Patients aged 18-40 years old are set as background\n\nExclusion Criteria:\n\n1. patients with central nervous system diseases and mental diseases\n2. preoperative minimal mental status examination(MMSE) score\\<24;\n3. ASA status III or higher\n\n3\\) those who have received less than 5 years of education since entering primary school; 4) history of sedatives or antidepressants use; 5) existed or anticipated alcohol or drug abuse(over 40°c and over 100ml per day for the past 3 months); 6) history of surgery within the previous year; 7) those with severe visual or hearing impairment; 8) those participated in other clinical studies within last 3 months;'}, 'identificationModule': {'nctId': 'NCT04219033', 'acronym': 'POEM', 'briefTitle': 'Postoperative Cognitive Function and EEG', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Correlation Between Postoperative Cognitive Function and EEG Parameters in Elderly Patients Undergoing Non-cardiac Major Surgery : Multi-center, Prospective, Observational Study', 'orgStudyIdInfo': {'id': 'XJH-A-20190726'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'with postoperative cognitive dysfunction', 'interventionNames': ['Other: EEG(Electroencephalogram) change']}, {'label': 'without postoperative dysfunction', 'interventionNames': ['Other: EEG(Electroencephalogram) change']}], 'interventions': [{'name': 'EEG(Electroencephalogram) change', 'type': 'OTHER', 'description': 'patients are found to have characteristic EEG change', 'armGroupLabels': ['with postoperative cognitive dysfunction', 'without postoperative dysfunction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fuhai Ji', 'role': 'CONTACT'}], 'facility': "Suzhou First People's Hospital", 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shibiao Chen', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yugang Diao', 'role': 'CONTACT'}], 'facility': 'General Hospital of Northern Theater Command', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Yinchuan', 'state': 'Ningxia', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinli Ni', 'role': 'CONTACT'}], 'facility': 'General Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}, {'city': 'Xining', 'state': 'Qinghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yun Wang', 'role': 'CONTACT'}], 'facility': "Qinhai Provincial People's Hospital", 'geoPoint': {'lat': 36.62554, 'lon': 101.75739}}, {'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianrui Lv', 'role': 'CONTACT'}], 'facility': "The Second Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shouyuan Tian', 'role': 'CONTACT'}], 'facility': 'First Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Linzhong Zhang', 'role': 'CONTACT'}], 'facility': 'Second Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chongfang Han', 'role': 'CONTACT'}], 'facility': 'Shanxi Bethune Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Yan', 'role': 'CONTACT', 'email': 'zryanmin@zju.edu.cn', 'phone': '0571-87767223'}], 'facility': 'The Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Zhao', 'role': 'CONTACT'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Li', 'role': 'CONTACT'}], 'facility': 'Xinqiao Hospital of Army Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Nanjing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Cunming Liu', 'role': 'CONTACT'}], 'facility': "People's Hospital of Jiangsu", 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Weinan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianzhong Ma', 'role': 'CONTACT'}], 'facility': 'Weinan Central Hospital', 'geoPoint': {'lat': 34.50355, 'lon': 109.50891}}, {'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mian Peng', 'role': 'CONTACT'}], 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Zhanjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tao Tao', 'role': 'CONTACT'}], 'facility': "People's Hospital of Zhanjiang", 'geoPoint': {'lat': 21.23391, 'lon': 110.38749}}, {'city': 'Zhengzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiaqiang Zhang', 'role': 'CONTACT'}], 'facility': "People's Hospital of Zhengzhou University", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Zhengzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xihua Lu', 'role': 'CONTACT'}], 'facility': 'Traditional Chinese Medicine Hospital of Henan', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Hailong Dong', 'role': 'CONTACT', 'email': 'hldong6@hotmail.com', 'phone': '862984775337'}, {'name': 'Zhihong Lu', 'role': 'CONTACT', 'email': 'deerlu23@163.com', 'phone': '8613891975018', 'phoneExt': '8613891975018'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Zhihong LU', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}