Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-29 @ 9:01 AM
Study NCT ID:
NCT05656703
Status:
COMPLETED
Last Update Posted:
2022-12-19
First Post:
2022-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthesia Depth Increases Delirium Incidence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D058926', 'term': 'Intraoperative Awareness'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'group blinding for all of the above except for staff anesthesiologist of the light anesthesia group'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised-controlled, double blind study, monocentric'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-12', 'studyFirstSubmitDate': '2022-05-12', 'studyFirstSubmitQcDate': '2022-12-12', 'lastUpdatePostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative delirium by NUDESC', 'timeFrame': '6 to 24 months', 'description': 'in the hospital with NUDESC Score'}, {'measure': 'postoperative dementia and cognitive deficit By MMSE and MAT Test', 'timeFrame': '6 to 24 months', 'description': 'in the hospital by MMSE and MAT (automated computerized test), after discharge by a standardized questionnaire'}, {'measure': 'awareness, memory function', 'timeFrame': '1 to 3 days postoperative', 'description': 'implicit and explicit memory for intraoperative wakefulness and memory functions in general as changing conditions due to anesthesia'}], 'secondaryOutcomes': [{'measure': 'mortality and morbidity', 'timeFrame': '6 to 24 months', 'description': 'death rate (in hospital and longterm mortality (death/month)) and complication rate (in hospital and longterm morbidity (complications/month))'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bispectral index monitoring', 'anesthesia depth'], 'conditions': ['Delirium', 'Anesthesia Awareness']}, 'descriptionModule': {'briefSummary': 'This study aimed to determine whether targeting bispectral index (BIS) readings of 55 (light anaesthesia) was associated with a lower incidence of delirium, dementia (POD), POCD and mortality but higher rates of awareness and complications than a standard of care anaesthesia blinded to depth monitoring.', 'detailedDescription': 'Design: Randomised-controlled, double blind study, monocentric Setting: Level 2 medical center, major surgery (non cardiac) Ethics: Ethical approval for this study (Ethikkommission II der Ruprecht-Karls-Universität Heidelberg 2013-627N-MA) was provided by the Ethical Committee II University Medicine Mannheim, University of Heidelberg, Germany (Chairperson Prof W. Striebel) on Mai 12th 2008.\n\nPatients: n=130, aged \\> 70y Intervention: Light anesthesia (BIS 55 +/-5) vs. Standard of Care (BIS- blinded) Main outcome measures: Incidence of awareness, delirium, postoperative cognitive deficit (POCD), dementia (POD), memory (MAT with a computerized score for verbal working\\&short term, figural working\\&short term memories and well as attention level) Second aims: mortality, complications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled for major surgery above 60 min duration\n* informed consent\n\nExclusion Criteria:\n\n* emergency surgery with large blood loss and/or preoperative cardiovascular instability, scheduled regional or neuraxial anesthesia, language barriers with the unability to understand a German audio tape, unability or unwillingness to consent,hearing disabilities'}, 'identificationModule': {'nctId': 'NCT05656703', 'briefTitle': 'Anesthesia Depth Increases Delirium Incidence', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Monitoring of Anesthesia Depth Reduces the Incidence of Postoperative Delirium and Preserves Memory Abilities Better in the High Risk Elderly', 'orgStudyIdInfo': {'id': '2013-627N-MA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bis Guided light anesthesia', 'description': 'Patients are monitored by bispectral index and held under light anesthesia (BIS level 45 to 60)', 'interventionNames': ['Device: BIS guidance of anesthesia']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard of Care', 'description': 'Patients receive standard of care anesthesia, BIS monitor was covered with a blind', 'interventionNames': ['Other: Standard of Care']}], 'interventions': [{'name': 'BIS guidance of anesthesia', 'type': 'DEVICE', 'description': 'Anesthesia is to be directed to a specific (light) level by the dosage of administered hypnotics and analgesics', 'armGroupLabels': ['Bis Guided light anesthesia']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Anesthesia is administered as usual', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Clinic of Anesthesiology and Critical Care Medicine, Faculty of Clinical Medicine MAnnheim, University of Heidelberg, Germany', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Thomas Frietsch', 'investigatorAffiliation': 'Heidelberg University'}}}}