Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2026-01-27 @ 4:11 AM
Study NCT ID:
NCT04292561
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2020-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative EEG Monitoring and Postoperative Delirium in Elderly Patients With Sevoflurane Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-23', 'studyFirstSubmitDate': '2020-01-08', 'studyFirstSubmitQcDate': '2020-02-29', 'lastUpdatePostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of POD', 'timeFrame': 'The 1st day after the surgery', 'description': 'Incidence of POD after surgery'}, {'measure': 'Incidence of POD', 'timeFrame': 'The 2nd day after the surgery', 'description': 'Incidence of POD after surgery'}, {'measure': 'Incidence of POD', 'timeFrame': 'The 3rd day after the surgery', 'description': 'Incidence of POD after surgery'}, {'measure': 'Incidence of POD', 'timeFrame': 'The 5th day after the surgery', 'description': 'Incidence of POD after surgery'}, {'measure': 'Incidence of POD', 'timeFrame': 'The 7th day after the surgery', 'description': 'Incidence of POD after surgery'}], 'secondaryOutcomes': [{'measure': 'EEG burst inhibition', 'timeFrame': 'During surgery', 'description': 'Frequency of EEG burst inhibition'}, {'measure': 'EEG burst inhibition', 'timeFrame': 'During surgery', 'description': 'Duration of EEG burst inhibition'}, {'measure': 'Incidence of adverse events', 'timeFrame': '30-day after surgery', 'description': 'Incidence of adverse events after surgery'}, {'measure': 'length of stay', 'timeFrame': 'From 1st day after the surgery to 2 weeks', 'description': 'length of stay after surgery'}, {'measure': '30-day mortality', 'timeFrame': '30-day after surgery', 'description': '30-day mortality after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Delirium', 'Sevoflurane', 'Electroencephalogram']}, 'referencesModule': {'references': [{'pmid': '22311257', 'type': 'BACKGROUND', 'citation': 'Chaput AJ, Bryson GL. Postoperative delirium: risk factors and management: continuing professional development. Can J Anaesth. 2012 Mar;59(3):304-20. doi: 10.1007/s12630-011-9658-4. Epub 2012 Feb 4. English, French.'}, {'pmid': '23027226', 'type': 'BACKGROUND', 'citation': 'Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. doi: 10.1097/ANA.0b013e3182712fba.'}, {'pmid': '26418126', 'type': 'BACKGROUND', 'citation': 'Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.'}, {'pmid': '30721296', 'type': 'BACKGROUND', 'citation': 'Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):473-483. doi: 10.1001/jama.2018.22005.'}, {'pmid': '25860600', 'type': 'BACKGROUND', 'citation': 'Ridaura V, Belkaid Y. Gut microbiota: the link to your second brain. Cell. 2015 Apr 9;161(2):193-4. doi: 10.1016/j.cell.2015.03.033.'}]}, 'descriptionModule': {'briefSummary': 'Delirium is an acute onset of attentional and cognitive impairment. BIS guided anesthesia can reduce the incidence of postoperative delirium. Long term electroencephalogram (EEG) suppression during operation is related to postoperative delirium. The latest research shows that the anesthesia depth guided by EEG does not reduce the incidence of postoperative delirium. The purpose of this study was to explore the relationship between anesthesia exposure with different minimum alveolar concentration(MAC) and postoperative delirium(POD), and to observe the characteristics of EEG.', 'detailedDescription': 'More and more studies have focused on the relationship between EEG inhibition and postoperative delirium in general anesthesia. At present, there are two kinds of commonly processed quantitative EEG monitoring to evaluate the depth of anesthesia, one is bispectral index (BIS) and the other is patient state index (PSI). The relationship between intraoperative anesthetic exposure and postoperative delirium is unclear, or whether potential patient characteristics increase the risk of EEG suppression and postoperative delirium.\n\nGastrointestinal surgery can lead to long-term changes in colonic flora, which can remotely regulate brain function through the gut brain axis. We speculated that the abnormal composition of intestinal flora before abdominal operation might be the influencing factor of POD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of gastrointestinal diseases\n* Patients were aged 60 to 90 years\n* American Society of Anesthesiologists (ASA) risk classification II-IV\n* Patients were scheduled to undergo elective major abdominal operation(with a anticipated time of 2-6 h)\n\nExclusion Criteria:\n\n* Preoperative dementia or cognitive impairment\n* Mental instability or mental illness\n* Patients with any factors affecting cognitive assessment, such as language, vision and hearing impairment\n* Any cerebrovascular accident occurred within 3 months, such as stroke etc\n* Previous history of delirium\n* Known hypersensitivity to sevoflurane or history of malignant hyperthermia\n* Abuse of narcotic sedative and analgesic drugs\n* Those who have reoperation within 7 days after operation'}, 'identificationModule': {'nctId': 'NCT04292561', 'briefTitle': 'Intraoperative EEG Monitoring and Postoperative Delirium in Elderly Patients With Sevoflurane Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Anhui Medical University'}, 'officialTitle': 'Effects of Different Sevoflurane Concentrations on Intraoperative EEG and Postoperative Delirium in Elderly Patients', 'orgStudyIdInfo': {'id': '201912'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'light general anesthesia', 'description': 'During anesthesia maintenance, patients were received with low concentration sevoflurane to maintain a target of 0.8 MAC.', 'interventionNames': ['Drug: Low MAC']}, {'type': 'EXPERIMENTAL', 'label': 'deep general anesthesia', 'description': 'During anesthesia maintenance, patients were received with high concentration sevoflurane to maintain a target of 1.0 MAC.', 'interventionNames': ['Drug: High MAC']}], 'interventions': [{'name': 'Low MAC', 'type': 'DRUG', 'description': 'To maintain a target of sevoflurane inhalation concentration 0.8 MAC.', 'armGroupLabels': ['light general anesthesia']}, {'name': 'High MAC', 'type': 'DRUG', 'description': 'To maintain a target of sevoflurane inhalation concentration 1.0 MAC.', 'armGroupLabels': ['deep general anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230022', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'overallOfficials': [{'name': 'Xuesheng Liu, MD.PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Anhui Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}