Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-31 @ 7:04 PM
Study NCT ID:
NCT04820595
Status:
COMPLETED
Last Update Posted:
2023-07-11
First Post:
2021-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Neurocognitive Dysfunction: Is There Any Place for Emergency Agitation: A Prospective Cohort Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}], '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'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-10', 'studyFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'frequency of postoperative delirium', 'timeFrame': '5 postoperative day', 'description': 'Percent of postoperative delirium'}, {'measure': 'frequency of postoperative cognitive dysfunction', 'timeFrame': '7 postoperative day', 'description': 'Percent of postoperative cognitive dysfunction'}], 'secondaryOutcomes': [{'measure': 'frequency of emergence agitation', 'timeFrame': 'immediately upon emergence from anesthesia', 'description': 'Percent of emergence agitation'}, {'measure': 'frequency of emergence delirium', 'timeFrame': 'immediately upon emergence from anesthesia', 'description': 'Percent of emergence delirium'}, {'measure': 'Length of postoperative delirium', 'timeFrame': '5 postoperative day', 'description': 'Day of the end of postoperative delirium - day of onset of postoperative delirium'}, {'measure': 'Length of stay in ICU', 'timeFrame': '1 year', 'description': 'From ICU admission to ICU discharge'}, {'measure': 'Length of hospitalization', 'timeFrame': '1 year', 'description': 'From operative day to hospital discharge'}, {'measure': 'MACE', 'timeFrame': '30 day', 'description': 'Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization'}, {'measure': 'MACE', 'timeFrame': '1 year', 'description': 'Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization'}, {'measure': 'MACCE', 'timeFrame': '30 day', 'description': 'Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization or Cerebrovascular accident'}, {'measure': 'MACCE', 'timeFrame': '1 year', 'description': 'Cardiac death or Myocardial infarction or Non-fatal cardiac arrest or Coronary revascularization or Cerebrovascular accident'}, {'measure': '30-day mortality', 'timeFrame': '30 day', 'description': '30-day mortality'}, {'measure': '1-year mortality', 'timeFrame': '1 year', 'description': '1-year mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['emergence agitation', 'postoperative agitation', 'postoperative delirium', 'postoperative cognitive dysfunction', 'emergence delirium'], 'conditions': ['Emergence Delirium', 'Emergence Agitation', 'Postoperative Delirium']}, 'descriptionModule': {'briefSummary': 'Perioperative neurocognitive disorders (PND) have been studying by clinicians, particularly by anesthesiologists, pretty long, however the most inspiring advancements were achieved during the last few decades. The most recent classification of PND which includes cognitive decline diagnosed before operation (described as neurocognitive disorder); any form of acute event (postoperative delirium) and cognitive decline diagnosed up to 30 days after the procedure (delayed neurocognitive recovery) and up to 12 months (postoperative neurocognitive disorder) was proposed in 2017. However at will one can notice at least one uncertainty that pertinent to the definition of delirium, emergency delirium and not mentioned in the classification discussed agitation.\n\nThe objective of the study is to determine if there is a difference between emergence agitation and emergence delirium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from 45 to 74 years old undergoing elective orthopedic surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 45 to 74 years\n* Undergoing elective orthopedic surgery\n* Provide written informed consent to participate in the PoD trial\n\nExclusion Criteria:\n\n* Undergoing emergent/urgent surgery\n* Montreal Cognitive Assessment \\< 18 points\n* History of mental disorders according ICD-11\n* Treated with at least one psychotropic drug\n* Patients with neuromuscular disease\n* Inability to undergo preoperative assessment for any reason\n* Previously enrolled in PoD trial'}, 'identificationModule': {'nctId': 'NCT04820595', 'acronym': 'PoD', 'briefTitle': 'Postoperative Neurocognitive Dysfunction: Is There Any Place for Emergency Agitation: A Prospective Cohort Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Negovsky Reanimatology Research Institute'}, 'officialTitle': 'Postoperative Neurocognitive Dysfunction: Is There Any Place for Emergency Agitation: A Prospective Cohort Trial', 'orgStudyIdInfo': {'id': 'PoD-2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'Patients who have RASS \\< +2 and have not delirium according CAM-ICU immediately upon emergence from anesthesia', 'interventionNames': ['Diagnostic Test: RASS', 'Diagnostic Test: CAM-ICU']}, {'label': 'Agitated non-delirious group', 'description': 'Patients who have RASS = +2 or more and have not delirium according CAM-ICU immediately upon emergence from anesthesia', 'interventionNames': ['Diagnostic Test: RASS', 'Diagnostic Test: CAM-ICU']}, {'label': 'Agitated delirium group', 'description': 'Patients who have RASS = +2 or more and have delirium according CAM-ICU immediately upon emergence from anesthesia', 'interventionNames': ['Diagnostic Test: RASS', 'Diagnostic Test: CAM-ICU']}], 'interventions': [{'name': 'RASS', 'type': 'DIAGNOSTIC_TEST', 'description': 'Richmond Agitation-Sedation Scale', 'armGroupLabels': ['Agitated delirium group', 'Agitated non-delirious group', 'Control group']}, {'name': 'CAM-ICU', 'type': 'DIAGNOSTIC_TEST', 'description': 'Confusion Assessment Method for the ICU', 'armGroupLabels': ['Agitated delirium group', 'Agitated non-delirious group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '111123', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow Scientific Clinical Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Main Military Clinical Hospital n.a. Acad.N. N. Burdenko', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Valery Likhvantsev', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Negovsky Reanimatology Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Negovsky Reanimatology Research Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Research Negovsky Reanimatology Research Institute', 'investigatorFullName': 'Valery Likhvantsev, MD', 'investigatorAffiliation': 'Negovsky Reanimatology Research Institute'}}}}