Viewing Study NCT02604459

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Ignite Creation Date: 2025-12-24 @ 2:31 PM
Ignite Modification Date: 2026-02-25 @ 9:49 PM
Study NCT ID: NCT02604459
Status: TERMINATED
Last Update Posted: 2023-10-17
First Post: 2015-11-04
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Does Optimized General Anesthesia Care Reduce Postoperative Delirium?
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'johnsonql@health.missouri.edu', 'phone': '573-882-2568', 'title': 'Dr. Quinn Johnson', 'organization': 'University of Missouri'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limited availability of subjects meeting inclusion criteria resulting in early termination (lack of funding) before meeting target enrollment.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Comparator: Usual General Anesthesia Care', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 25, 'seriousNumAtRisk': 56, 'deathsNumAffected': 8, 'seriousNumAffected': 26}, {'id': 'EG001', 'title': 'Experimental: Optimized General Anesthesia Care', 'description': 'The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 20, 'seriousNumAtRisk': 53, 'deathsNumAffected': 6, 'seriousNumAffected': 28}, {'id': 'EG002', 'title': 'Mini Mental State Exam', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 10, 'seriousNumAffected': 11}, {'id': 'EG003', 'title': 'Tested and Excluded', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Superficial incisional surgical site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transfusion of packed red blood cells', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Organ/space surgical site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unplanned intubation', 'notes': 'Assessed in the intraoperative or postoperative period of index hospitalization.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspiration pneumonitis/pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax with chest tube', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke/cerebral vascular attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transfusion of packed red blood cells', 'notes': 'Required high volume transfusion.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intensive care unit admission', 'notes': 'Assessed during index hospitalization.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercalcemia/urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep incisional surgical site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute hypoxic respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical hardware removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Superficial incisional surgical site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Maxillary sinus tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia/dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'T12-L1 spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulcers', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest requiring cardiopulmonary resuscitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pituitary tumor', 'notes': 'Surgical removal requiring hospitalization.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Avascular necrosis of femoral head', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Total knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-ST-elevation myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic ring fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis/cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Carotid endarterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg surgery', 'notes': 'Surgical repair of knee and foot requiring hospital readmission.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Knee replacement surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Altered mental status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tibia/fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Organ/space surgical site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Melena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Failed open reduction internal fixation of patella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Liver failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Severity of Postoperative Delirium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator: Usual General Anesthesia Care', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane'}, {'id': 'OG001', 'title': 'Experimental: Optimized General Anesthesia Care', 'description': 'The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.'}, {'id': 'OG002', 'title': 'Mini Mental State Exam', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane.'}, {'id': 'OG003', 'title': 'Tested and Excluded', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '0.63', 'spread': '0.49', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 postoperative days', 'description': 'Delirium Rating Scale-Revised-98 (DRS-R-98) is a 16-item clinician-rated scale with 13 severity items and 3 diagnostic items (maximum severity score of 39 points). Higher scores indicate more severe delirium; score of 0 indicates no delirium. Only the number of patients who had high scores on the DRS-R-98 are reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients who presented with postoperative delirium and had high scores on the delirium test measures per group are indicated here. Patients who were excluded were not assessed for postoperative delirium.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Presented With Postoperative Delirium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator: Usual General Anesthesia Care', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane'}, {'id': 'OG001', 'title': 'Experimental: Optimized General Anesthesia Care', 'description': 'The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.'}, {'id': 'OG002', 'title': 'Mini Mental State Exam', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane'}, {'id': 'OG003', 'title': 'Tested and Excluded', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 postoperative days', 'description': "Confusion Assessment Method (CAM) with delirium scored as 'present' (1) or 'absent' (0) based on question responses; CAM is considered positive based on the CAM algorithm: presence of acute onset or fluctuating course, inattention, and disorganized thinking or altered level of consciousness.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients who presented with postoperative delirium are reported. The patients who where tested and then excluded were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Perioperative Inflammatory Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator: Usual General Anesthesia Care', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane'}, {'id': 'OG001', 'title': 'Experimental: Optimized General Anesthesia Care', 'description': 'The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.'}, {'id': 'OG002', 'title': 'Mini Mental State Exam', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane'}, {'id': 'OG003', 'title': 'Tested and Excluded', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane'}], 'timeFrame': 'preoperative, day of surgery, and postoperative day 2', 'description': 'Blood will be drawn for analysis of inflammatory markers including interleukin 6 (IL6), interleukin 10 (IL10), tumor necrosis factor (TNF) alpha on the day prior to surgery, at the end of surgery and on the second postoperative day.', 'reportingStatus': 'POSTED', 'populationDescription': 'Lack of funding prevented the analysis of blood to obtain inflammatory markers.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Experienced Postoperative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator: Usual General Anesthesia Care', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane'}, {'id': 'OG001', 'title': 'Experimental: Optimized General Anesthesia Care', 'description': 'The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.'}, {'id': 'OG002', 'title': 'Mini Mental State Exam', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane'}, {'id': 'OG003', 'title': 'Tested and Excluded', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane'}], 'classes': [{'title': '3 Months: Cardiac arrest requiring cardiopulmonary resuscitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '3 Months: Myocardial infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '3 Months: Both cardiac arrest requiring cardiopulmonary resuscitation and myocardial infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '3 Months: Deep incisional surgical site infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '3 Months: Organ/space surgical site infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '1 Year: Cardiac arrest requiring cardiopulmonary resuscitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '1 Year: Myocardial infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '1 Year: Both cardiac arrest requiring cardiopulmonary resuscitation and myocardial infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '1 Year: Deep incisional surgical site infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '1 Year: Organ/space surgical site infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months and 1 year', 'description': 'The investigators will make a telephone call to the subjects at 3 months and 1 year after surgery to determine if the subject has experienced any complications. We will ask the subjects about the occurrence of infections, strokes, cardiac problems, or respiratory problems since discharge from the hospital.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed in rows differs due to loss to follow-up. Patients who were excluded from the study were not followed op post operatively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual General Anesthesia Care', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane\n\nGeneral anesthesia: General anesthesia will be used in both groups\n\npropofol: propofol per protocol\n\nfentanyl: fentanyl per protocol\n\nsevoflurane: maintenance of anesthesia with inhaled sevoflurane'}, {'id': 'FG001', 'title': 'Optimized General Anesthesia Care', 'description': 'The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.\n\ncerebral oximeter (Fore-Sight): The cerebral oximeter will be monitored in the optimized care group and cerebral oxygenation will be maintained at 60% or higher.\n\ndepth of anesthesia monitor (BIS): The depth of anesthesia will be maintained between 40 and 60 in the optimized care group.\n\nBP management: The systolic blood pressure will be maintained within 20% of preoperative levels in the optimized care group.\n\nGeneral anesthesia: General anesthesia will be used in both groups\n\npropofol: propofol per protocol\n\nfentanyl: fentanyl per protocol\n\nsevoflurane: maintenance of anesthesia with inhaled sevoflurane'}, {'id': 'FG002', 'title': 'Mini-Mental State Examination', 'description': 'If a patient is enrolled in the study, but scores \\< 15 on the MMSE, they will remain in the study but will not be randomized to one of the treatment groups. They will receive the same type of general anesthesia for their hip fracture surgery as that done for randomized subjects. They will not be monitored with bispectral index or cerebral oximetry during the surgical procedure.'}, {'id': 'FG003', 'title': 'Tested and Excluded', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '145', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Comparator: Usual General Anesthesia Care', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane'}, {'id': 'BG001', 'title': 'Experimental: Optimized General Anesthesia Care', 'description': 'The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.'}, {'id': 'BG002', 'title': 'Mini Mental State Exam', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane'}, {'id': 'BG003', 'title': 'Tested and Excluded', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '78.1', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '77.8', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '86.6', 'spread': '6.8', 'groupId': 'BG002'}, {'value': '81', 'spread': '7.9', 'groupId': 'BG003'}, {'value': '78', 'spread': '8.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '142', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'American Society of Anesthesiologists (ASA) Physical Status Classification System', 'classes': [{'categories': [{'title': '2', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}, {'title': '3', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}]}, {'title': '4', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The ASA Physical Status Classification System is used to assess and communicate a patient's pre-anesthesia medical co-morbidities. Scale: 1-6.\n\nA higher ASA Physical Status score indicates more severe systemic disease. Patients with a higher score is generally at higher risk for complications.", 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analysis of active comparator arm (usual general anesthesia care) and experimental arm (optimized general anesthesia care).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-20', 'size': 341645, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-11T08:47', 'hasProtocol': True}, {'date': '2017-11-15', 'size': 130684, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-09-08T10:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The individuals assessing the patients for delirium after surgery will be unaware of the treatment in the operating room.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'whyStopped': 'Limited availability of subjects meeting inclusion criteria resulting in early termination (lack of funding) before meeting target enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-28', 'studyFirstSubmitDate': '2015-11-04', 'resultsFirstSubmitDate': '2023-06-16', 'studyFirstSubmitQcDate': '2015-11-12', 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-28', 'studyFirstPostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of Postoperative Delirium', 'timeFrame': '5 postoperative days', 'description': 'Delirium Rating Scale-Revised-98 (DRS-R-98) is a 16-item clinician-rated scale with 13 severity items and 3 diagnostic items (maximum severity score of 39 points). Higher scores indicate more severe delirium; score of 0 indicates no delirium. Only the number of patients who had high scores on the DRS-R-98 are reported.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Who Presented With Postoperative Delirium', 'timeFrame': '5 postoperative days', 'description': "Confusion Assessment Method (CAM) with delirium scored as 'present' (1) or 'absent' (0) based on question responses; CAM is considered positive based on the CAM algorithm: presence of acute onset or fluctuating course, inattention, and disorganized thinking or altered level of consciousness."}, {'measure': 'Perioperative Inflammatory Response', 'timeFrame': 'preoperative, day of surgery, and postoperative day 2', 'description': 'Blood will be drawn for analysis of inflammatory markers including interleukin 6 (IL6), interleukin 10 (IL10), tumor necrosis factor (TNF) alpha on the day prior to surgery, at the end of surgery and on the second postoperative day.'}, {'measure': 'Number of Patients Who Experienced Postoperative Complications', 'timeFrame': '3 months and 1 year', 'description': 'The investigators will make a telephone call to the subjects at 3 months and 1 year after surgery to determine if the subject has experienced any complications. We will ask the subjects about the occurrence of infections, strokes, cardiac problems, or respiratory problems since discharge from the hospital.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hip Fractures', 'Anesthesia', 'Delirium']}, 'descriptionModule': {'briefSummary': 'Postoperative delirium occurs in up to 65% of elders undergoing surgery for repair of a hip fracture and this complication is independently associated with increased morbidity, mortality, length of hospital stay, and placement in long-term care institutions. To date, the only intervention shown to be effective at minimizing postoperative delirium is a proactive geriatric consultation. This prospective randomized clinical trial will randomize 160 adults, aged 65 years or older, to either optimized general anesthesia or usual general anesthesia care for hip fracture surgery to determine if the optimized anesthesia management reduces the severity of postoperative delirium.', 'detailedDescription': 'Subjects will be randomized to one of two intraoperative anesthesia treatment groups: 1.) Usual care - the anesthetic management will be at the discretion of the anesthesia provider; or 1.) Optimal care - the intraoperative depth of anesthesia will be directed using a BIS monitor, blood pressure will be maintained within 20% of preoperative levels, and cerebral oxygenation will be maintained \\> 60% during anesthesia. Subjects will be evaluated using the Confusion Assessment Method (CAM) for the first 5 postoperative days to determine if they experience postoperative delirium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject or legal representative has voluntarily signed the informed consent approved by the Institutional Review Board,\n* Hip fracture surgery scheduled under general anesthesia\n* Subject is 65 years or older on the day of surgery\n\nExclusion Criteria:\n\n* Inability to follow directions or comprehend the English language\n* Severe uncorrected visual or auditory handicaps\n* Delirium at screening or baseline\n* Emergency surgery'}, 'identificationModule': {'nctId': 'NCT02604459', 'acronym': 'OPCare', 'briefTitle': 'Does Optimized General Anesthesia Care Reduce Postoperative Delirium?', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Does Optimized General Anesthesia Care Reduce Postoperative Delirium In Older Patients Undergoing Hip Fracture Repair?', 'orgStudyIdInfo': {'id': '1212915'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual general anesthesia care', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane', 'interventionNames': ['Procedure: General anesthesia', 'Drug: propofol', 'Drug: fentanyl', 'Drug: sevoflurane']}, {'type': 'EXPERIMENTAL', 'label': 'Optimized general anesthesia care', 'description': 'The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.', 'interventionNames': ['Device: cerebral oximeter (Fore-Sight)', 'Device: depth of anesthesia monitor (BIS)', 'Procedure: BP management', 'Procedure: General anesthesia', 'Drug: propofol', 'Drug: fentanyl', 'Drug: sevoflurane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mini Mental State Exam', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane', 'interventionNames': ['Procedure: General anesthesia', 'Drug: propofol', 'Drug: fentanyl', 'Drug: sevoflurane']}, {'type': 'OTHER', 'label': 'Tested and Excluded', 'description': 'Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.\n\nGeneral anesthesia with be maintained with propofol, fentanyl, sevoflurane', 'interventionNames': ['Procedure: General anesthesia', 'Drug: propofol', 'Drug: fentanyl', 'Drug: sevoflurane']}], 'interventions': [{'name': 'cerebral oximeter (Fore-Sight)', 'type': 'DEVICE', 'description': 'The cerebral oximeter will be monitored in the optimized care group and cerebral oxygenation will be maintained at 60% or higher.', 'armGroupLabels': ['Optimized general anesthesia care']}, {'name': 'depth of anesthesia monitor (BIS)', 'type': 'DEVICE', 'description': 'The depth of anesthesia will be maintained between 40 and 60 in the optimized care group.', 'armGroupLabels': ['Optimized general anesthesia care']}, {'name': 'BP management', 'type': 'PROCEDURE', 'description': 'The systolic blood pressure will be maintained within 20% of preoperative levels in the optimized care group.', 'armGroupLabels': ['Optimized general anesthesia care']}, {'name': 'General anesthesia', 'type': 'PROCEDURE', 'description': 'General anesthesia will be used in both groups', 'armGroupLabels': ['Mini Mental State Exam', 'Optimized general anesthesia care', 'Tested and Excluded', 'Usual general anesthesia care']}, {'name': 'propofol', 'type': 'DRUG', 'otherNames': ['diprivan'], 'description': 'propofol per protocol', 'armGroupLabels': ['Mini Mental State Exam', 'Optimized general anesthesia care', 'Tested and Excluded', 'Usual general anesthesia care']}, {'name': 'fentanyl', 'type': 'DRUG', 'otherNames': ['sublimaze'], 'description': 'fentanyl per protocol', 'armGroupLabels': ['Mini Mental State Exam', 'Optimized general anesthesia care', 'Tested and Excluded', 'Usual general anesthesia care']}, {'name': 'sevoflurane', 'type': 'DRUG', 'otherNames': ['ultane'], 'description': 'maintenance of anesthesia with inhaled sevoflurane', 'armGroupLabels': ['Mini Mental State Exam', 'Optimized general anesthesia care', 'Tested and Excluded', 'Usual general anesthesia care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri Hospitals', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Quinn L Johnson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair, Anesthesiology', 'investigatorFullName': 'Quinn Johnson', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}