Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-27 @ 11:59 AM
Study NCT ID:
NCT06102967
Status:
COMPLETED
Last Update Posted:
2024-08-23
First Post:
2023-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EEG Characteristics and Postoperative Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D000073496', 'term': 'Frailty'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2023-10-09', 'studyFirstSubmitQcDate': '2023-10-21', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative delirium', 'timeFrame': '1 day, 2 days, 3 days, and 7 days after surgery', 'description': 'Assessing delirium using the ICU Patient Ambiguity Assessment Form (CAM-ICU)'}, {'measure': 'EEG power of each band', 'timeFrame': 'During the procedure', 'description': 'Recording frontal lobe electroencephalogram using a sedline root monitor (Masimo, Crop)'}, {'measure': 'The number of minutes of suppression assessed by visual analysis of the EEG', 'timeFrame': 'Throughout the operation', 'description': 'The burst suppression time was calculated by EEG visual analysis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Delirium', 'Cognitive Function Abnormal', 'PSI', 'Frailty']}, 'descriptionModule': {'briefSummary': 'The goal of this \\[type of study: observational study \\] is to \\[compare Energy differences in various bands of intraoperative electroencephalogram in elderly patients with postoperative delirium and non delirium.\\] in \\[describe participant population selected 69 patients who underwent laparoscopic radical surgery for colorectal cancer on a selective basis\\]. The main question\\[s\\] it aims to answer are:\n\n• \\[Is there any difference in the spectral range of EEG between POD patients and non POD patients\\] Participants will \\[Cognitive.•Postoperative delirium.•Preoperative weakness.\\]', 'detailedDescription': 'The goal of this \\[type of study: observational study \\] is to \\[compare Correlation between EEG data and postoperative delirium in elderly patients undergoing colorectal cancer radical surgery under preoperative frailty monitoring.\\] in \\[describe participant population selected 69 patients who underwent laparoscopic radical surgery for colorectal cancer on a selective basis\\]. The main question\\[s\\] it aims to answer are:\n\n• \\[Is there any difference in the spectral range of EEG between POD patients and non POD patients\\] Participants will \\[Sedline EEG monitoring electrodes were placed 1cm above the eyebrows on both sides of the patient and at the temples on both sides, and were continuously monitored from the start of anesthesia in the operating room until the end of the surgery.Pay close attention to the vital signs and wait for the patient to fully recover and the vital signs to basically return to the preoperative level before returning to the ward.•Assessment of cognitive function using the Mini Mental State Scale (MMSE) 1 day before surgery and 7 days after surgery.•Preoperative assessment of frailty using the frailty screening scale.•Assess delirium using the ICU Patient Ambiguity Assessment Form (CAM-ICU) 1 day, 2 days, 3 days, and 7 days after surgery.\\].'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing laparoscopic radical surgery for colorectal cancer on a scheduled basis.Age ≥ 65 years old, regardless of gender; ASA grading I to III; The preoperative frailty scale (FRAIL) was evaluated as frailty; The patient or their family members voluntarily sign an informed consent form.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III\n* The preoperative Frailty Scale (FRAIL) assessed frailty\n* The patient or his/her family is informed about the study and signs an informed consent form\n\nExclusion Criteria:\n\n* Serious insufficiency of heart, liver, kidney and other functions\n* Those with a history of psychiatric or neurological illness, long-term use of psychotropic drug\n* History of cerebrovascular disease, brain trauma, or surgery\n* The patient was allergic to coupler or unable to place electrodes on the head\n* The patient was unable to complete the scale assessment as required.Patients with severe attention to hearing impairment were unable to complete the interview\n* The patient was diagnosed with delirium before surgery'}, 'identificationModule': {'nctId': 'NCT06102967', 'briefTitle': 'EEG Characteristics and Postoperative Delirium', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The First Hospital of Qinhuangdao'}, 'officialTitle': 'Correlation Between Intraoperative Electroencephalographic Signatures and Postoperative Delirium in Preoperative Frail Elderly Patients Undergoing', 'orgStudyIdInfo': {'id': 'lzh123456'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-delirious group', 'description': 'No postoperative delirium occurred'}, {'label': 'Delirious group', 'description': 'Postoperative delirium occurs', 'interventionNames': ['Behavioral: delirium']}], 'interventions': [{'name': 'delirium', 'type': 'BEHAVIORAL', 'description': 'Evaluation of delirium using the ICU Patient Ambiguity Assessment Form (CAM-ICU) 1 day, 2 days, 3 days, and 7 days after surgery', 'armGroupLabels': ['Delirious group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '066000', 'city': 'Qinhuangdao', 'state': 'Hebei', 'country': 'China', 'facility': 'The first hospital of Qinhuangdao', 'geoPoint': {'lat': 39.94104, 'lon': 119.58936}}], 'overallOfficials': [{'name': 'Qinshuang Liu, master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First hosptial of Qinhuangdao'}, {'name': 'Zhaoheng Li, master', 'role': 'STUDY_CHAIR', 'affiliation': 'The First hosptial of Qinhuangdao'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhuo Liu', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhuo Liu', 'investigatorAffiliation': 'The First Hospital of Qinhuangdao'}}}}