Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-28 @ 2:40 AM
Study NCT ID:
NCT04601350
Status:
COMPLETED
Last Update Posted:
2024-01-16
First Post:
2020-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Remimazolam Use During Perioperative Period on Brain Waves and Postoperative Cognitive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C522201', 'term': 'remimazolam'}, {'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-11', 'studyFirstSubmitDate': '2020-10-05', 'studyFirstSubmitQcDate': '2020-10-22', 'lastUpdatePostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The average intraoperative power spectral density in the frontal alpha band', 'timeFrame': 'Preoperatively, During operation，End of operation', 'description': 'EEG data were collected at the beginning of the room admission, and the collection was ended at the end of the operation.'}, {'measure': 'Changes in the score of MMSE', 'timeFrame': 'The outcome above should be measured the day before surgery and 1,2,3,5,7 days after surgery', 'description': 'The outcome above should be measured the day before surgery and 1,2,3,5,7 days after surgery'}], 'secondaryOutcomes': [{'measure': 'Changes in IL-6, IL-10, and S100-β levels', 'timeFrame': 'The outcome above should be measured the day before surgery and 1，3 days after surgery', 'description': 'The outcome above should be measured the day before surgery and 1，3 days after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['remimazolam', 'recovery'], 'conditions': ['Benzodiazepine']}, 'descriptionModule': {'briefSummary': 'Benzodiazepine sedative hypnotics are commonly used intravenous anesthetics in clinical practice. Remimazolam is a new benzodiazepine with the characteristics of rapid onset, short maintenance and recovery time, no accumulation, metabolism independent of liver and kidney function, and no serious side effects, which has a good prospect for clinical application. Now we will study the effects of remimazolam on EEG and postoperative cognitive function ，in order to further understand the clinical application of remimazolam.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASAⅠ-Ⅱ\n* Patients undergoing elective surgery under general anesthesia.\n* Age, sex, and weight were not limited.\n\nExclusion Criteria:\n\n* Allergic or contraindication to remimazolam/midazolam/remifentanil;\n* Abnormal liver and kidney function; Alcohol abuse;\n* Long-term use of sedative, analgesic or anxiolytic drugs;\n* Hearing and language communication disorders;\n* Complicated with severe cardiovascular lesions or neurological diseases.'}, 'identificationModule': {'nctId': 'NCT04601350', 'briefTitle': 'Effect of Remimazolam Use During Perioperative Period on Brain Waves and Postoperative Cognitive Function', 'organization': {'class': 'OTHER', 'fullName': 'Yangzhou University'}, 'officialTitle': 'Effect of Remimazolam Use During Perioperative Period on Brain Waves and Postoperative Cognitive Function', 'orgStudyIdInfo': {'id': '20200922'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remimazolam 1', 'interventionNames': ['Drug: remimazolam group was induced with remimazolam 0.1 mg/kg followed by a maintenance dose of 0.1 mg·kg-1·h-1 for general anesthesia']}, {'type': 'OTHER', 'label': 'Control', 'interventionNames': ['Drug: control group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1']}], 'interventions': [{'name': 'remimazolam group was induced with remimazolam 0.1 mg/kg followed by a maintenance dose of 0.1 mg·kg-1·h-1 for general anesthesia', 'type': 'DRUG', 'description': 'remimazolam group was remimazolam 0.1 mg/kg followed by a maintenance dose of 0.1 mg·kg-1·h-1 for general anesthesia', 'armGroupLabels': ['Remimazolam 1']}, {'name': 'control group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1', 'type': 'DRUG', 'description': 'control group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yangzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'the Affiliated Hospital of Yangzhou University, Yangzhou University', 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yangzhou University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Zhuan Zhang', 'investigatorAffiliation': 'Yangzhou University'}}}}