Does Optimized General Anesthesia Care Reduce Postoperative Delirium?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Does Optimized General Anesthesia Care Reduce Postoperative Delirium In Older Patients Undergoing Hip Fracture Repair?

Conditions
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Hip Fractures, Anesthesia, Delirium

Intervention / Treatment
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* Device: cerebral oximeter (Fore-Sight)
* Device: depth of anesthesia monitor (BIS)
* Procedure: BP management
* Procedure: General anesthesia
* Drug: propofol
* Drug: fentanyl
* Drug: sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject or legal representative has voluntarily signed the informed consent approved by the Institutional Review Board, Hip fracture surgery scheduled under general anesthesia Subject is 65 years or older on the day of surgery Exclusion Criteria: Inability to follow directions or comprehend the English language Severe uncorrected visual or auditory handicaps Delirium at screening or baseline Emergency surgery

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual general anesthesia care<br>Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane | Procedure: General anesthesia<br>* General anesthesia will be used in both groups<br>Drug: propofol<br>* propofol per protocol<br>* Other names: diprivan;Drug: fentanyl<br>* fentanyl per protocol<br>* Other names: sublimaze;Drug: sevoflurane<br>* maintenance of anesthesia with inhaled sevoflurane<br>* Other names: ultane;|
| Experimental: Optimized general anesthesia care<br>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. | Device: cerebral oximeter (Fore-Sight)<br>* The cerebral oximeter will be monitored in the optimized care group and cerebral oxygenation will be maintained at 60% or higher.<br>Device: depth of anesthesia monitor (BIS)<br>* The depth of anesthesia will be maintained between 40 and 60 in the optimized care group.<br>Procedure: BP management<br>* The systolic blood pressure will be maintained within 20% of preoperative levels in the optimized care group.<br>Procedure: General anesthesia<br>* General anesthesia will be used in both groups<br>Drug: propofol<br>* propofol per protocol<br>* Other names: diprivan;Drug: fentanyl<br>* fentanyl per protocol<br>* Other names: sublimaze;Drug: sevoflurane<br>* maintenance of anesthesia with inhaled sevoflurane<br>* Other names: ultane;|
| Active Comparator: Mini Mental State Exam<br>Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane | Procedure: General anesthesia<br>* General anesthesia will be used in both groups<br>Drug: propofol<br>* propofol per protocol<br>* Other names: diprivan;Drug: fentanyl<br>* fentanyl per protocol<br>* Other names: sublimaze;Drug: sevoflurane<br>* maintenance of anesthesia with inhaled sevoflurane<br>* Other names: ultane;|
| Other: Tested and Excluded<br>Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane | Procedure: General anesthesia<br>* General anesthesia will be used in both groups<br>Drug: propofol<br>* propofol per protocol<br>* Other names: diprivan;Drug: fentanyl<br>* fentanyl per protocol<br>* Other names: sublimaze;Drug: sevoflurane<br>* maintenance of anesthesia with inhaled sevoflurane<br>* Other names: ultane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |