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Limited availability of subjects meeting inclusion criteria resulting in early termination (lack of funding) before meeting target enrollment.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual general anesthesia care | Active Comparator | Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane |
|
| Optimized general anesthesia care | Experimental | 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. |
|
| Mini Mental State Exam | Active Comparator | Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane |
|
| Tested and Excluded | Other | Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cerebral oximeter (Fore-Sight) | Device | The cerebral oximeter will be monitored in the optimized care group and cerebral oxygenation will be maintained at 60% or higher. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Postoperative Delirium | 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. | 5 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Presented With Postoperative Delirium | 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. | 5 postoperative days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quinn L Johnson, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri Hospitals | Columbia | Missouri | 65203 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual General Anesthesia Care | Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane General anesthesia: General anesthesia will be used in both groups propofol: propofol per protocol fentanyl: fentanyl per protocol sevoflurane: maintenance of anesthesia with inhaled sevoflurane |
| FG001 | Optimized General Anesthesia Care | 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. cerebral oximeter (Fore-Sight): The cerebral oximeter will be monitored in the optimized care group and cerebral oxygenation will be maintained at 60% or higher. depth of anesthesia monitor (BIS): The depth of anesthesia will be maintained between 40 and 60 in the optimized care group. BP management: The systolic blood pressure will be maintained within 20% of preoperative levels in the optimized care group. General anesthesia: General anesthesia will be used in both groups propofol: propofol per protocol fentanyl: fentanyl per protocol sevoflurane: maintenance of anesthesia with inhaled sevoflurane |
| FG002 | Mini-Mental State Examination | 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. |
| FG003 | Tested and Excluded | Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline analysis of active comparator arm (usual general anesthesia care) and experimental arm (optimized general anesthesia care).
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator: Usual General Anesthesia Care | Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane |
| BG001 | Experimental: Optimized General Anesthesia Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Severity of Postoperative Delirium | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 5 postoperative days |
|
1 year
Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Comparator: Usual General Anesthesia Care | Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superficial incisional surgical site infection | Infections and infestations | Systematic Assessment |
Limited availability of subjects meeting inclusion criteria resulting in early termination (lack of funding) before meeting target enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Quinn Johnson | University of Missouri | 573-882-2568 | johnsonql@health.missouri.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2017 | Jul 11, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 15, 2017 | Sep 8, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D015742 | Propofol |
| D005283 | Fentanyl |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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The individuals assessing the patients for delirium after surgery will be unaware of the treatment in the operating room.
|
| depth of anesthesia monitor (BIS) | Device | The depth of anesthesia will be maintained between 40 and 60 in the optimized care group. |
|
| BP management | Procedure | The systolic blood pressure will be maintained within 20% of preoperative levels in the optimized care group. |
|
| General anesthesia | Procedure | General anesthesia will be used in both groups |
|
| propofol | Drug | propofol per protocol |
|
|
| fentanyl | Drug | fentanyl per protocol |
|
|
| sevoflurane | Drug | maintenance of anesthesia with inhaled sevoflurane |
|
|
| Perioperative Inflammatory Response | 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. | preoperative, day of surgery, and postoperative day 2 |
| Number of Patients Who Experienced Postoperative Complications | 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. | 3 months and 1 year |
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. |
| BG002 | Mini Mental State Exam | Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane |
| BG003 | Tested and Excluded | Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| American Society of Anesthesiologists (ASA) Physical Status Classification System | The ASA Physical Status Classification System is used to assess and communicate a patient's pre-anesthesia medical co-morbidities. Scale: 1-6. A higher ASA Physical Status score indicates more severe systemic disease. Patients with a higher score is generally at higher risk for complications. | Count of Participants | Participants |
|
| OG001 | Experimental: Optimized General Anesthesia Care | 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. |
| OG002 | Mini Mental State Exam | Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane. |
| OG003 | Tested and Excluded | Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane. |
|
|
| Secondary | Number of Patients Who Presented With Postoperative Delirium | 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. | Number of patients who presented with postoperative delirium are reported. The patients who where tested and then excluded were not included in this analysis. | Posted | Count of Participants | Participants | 5 postoperative days |
|
|
|
| Secondary | Perioperative Inflammatory Response | 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. | Lack of funding prevented the analysis of blood to obtain inflammatory markers. | Posted | preoperative, day of surgery, and postoperative day 2 |
|
|
| Secondary | Number of Patients Who Experienced Postoperative Complications | 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. | Number analyzed in rows differs due to loss to follow-up. Patients who were excluded from the study were not followed op post operatively. | Posted | Count of Participants | Participants | 3 months and 1 year |
|
|
|
| 8 |
| 56 |
| 26 |
| 56 |
| 25 |
| 56 |
| EG001 | Experimental: Optimized General Anesthesia Care | 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. | 6 | 53 | 28 | 53 | 20 | 53 |
| EG002 | Mini Mental State Exam | Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane | 10 | 22 | 11 | 22 | 0 | 22 |
| EG003 | Tested and Excluded | Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane | 0 | 0 | 0 | 0 | 0 | 0 |
| Unplanned intubation | Injury, poisoning and procedural complications | Systematic Assessment | Assessed in the intraoperative or postoperative period of index hospitalization. |
|
| Aspiration pneumonitis/pneumonia | Infections and infestations | Systematic Assessment |
|
| Pneumothorax with chest tube | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Stroke/cerebral vascular attack | Nervous system disorders | Systematic Assessment |
|
| Transfusion of packed red blood cells | Injury, poisoning and procedural complications | Systematic Assessment | Required high volume transfusion. |
|
| Intensive care unit admission | Injury, poisoning and procedural complications | Systematic Assessment | Assessed during index hospitalization. |
|
| Death | General disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypercalcemia/urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Deep incisional surgical site infection | Infections and infestations | Systematic Assessment |
|
| Acute hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hip dislocation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Surgical hardware removal | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Severe aortic stenosis | Cardiac disorders | Systematic Assessment |
|
| Superficial incisional surgical site infection | Infections and infestations | Systematic Assessment |
|
| Maxillary sinus tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Abdominal swelling | Metabolism and nutrition disorders | Systematic Assessment |
|
| Dysphagia/dysphonia | Gastrointestinal disorders | Systematic Assessment |
|
| T12-L1 spinal fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Ulcers | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Eye surgery | Eye disorders | Systematic Assessment |
|
| Cardiac arrest requiring cardiopulmonary resuscitation | Cardiac disorders | Systematic Assessment |
|
| Bone fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pituitary tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Surgical removal requiring hospitalization. |
|
| Avascular necrosis of femoral head | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hypotension | General disorders | Systematic Assessment |
|
| Inguinal hernia | Surgical and medical procedures | Systematic Assessment |
|
| Total knee arthroplasty | Surgical and medical procedures | Systematic Assessment |
|
| Non-ST-elevation myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Pelvic ring fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cholecystitis/cholecystectomy | Surgical and medical procedures | Systematic Assessment |
|
| Leg pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Carotid endarterectomy | Surgical and medical procedures | Systematic Assessment |
|
| Respiratory distress | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Leg surgery | Surgical and medical procedures | Systematic Assessment | Surgical repair of knee and foot requiring hospital readmission. |
|
| Knee replacement surgery | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | Systematic Assessment |
|
| Altered mental status | Psychiatric disorders | Systematic Assessment |
|
| Tibia/fibula fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Organ/space surgical site infection | Infections and infestations | Systematic Assessment |
|
| Dysarthria | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Melena | Gastrointestinal disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Failed open reduction internal fixation of patella | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Liver failure | Endocrine disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Transfusion of packed red blood cells | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Organ/space surgical site infection | Infections and infestations | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D007869 |
| Leg Injuries |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
|
| 3 Months: Myocardial infarction |
|
|
| 3 Months: Both cardiac arrest requiring cardiopulmonary resuscitation and myocardial infarction |
|
|
| 3 Months: Deep incisional surgical site infection |
|
|
| 3 Months: Organ/space surgical site infection |
|
|
| 1 Year: Cardiac arrest requiring cardiopulmonary resuscitation |
|
|
| 1 Year: Myocardial infarction |
|
|
| 1 Year: Both cardiac arrest requiring cardiopulmonary resuscitation and myocardial infarction |
|
|
| 1 Year: Deep incisional surgical site infection |
|
|
| 1 Year: Organ/space surgical site infection |
|
|