Does Optimized General Anesthesia Care Reduce Postoperative Delirium?

Not Applicable

Terminated

Conditions: Hip Fractures
Anesthesia
Delirium

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

Registration Number: NCT02604459

Lead Sponsor: University of Missouri-Columbia

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 145

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tested and Excluded	General anesthesia	Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
Usual general anesthesia care	General anesthesia	Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
Usual general anesthesia care	propofol	Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
Usual general anesthesia care	fentanyl	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	cerebral oximeter (Fore-Sight)	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.
Optimized general anesthesia care	depth of anesthesia monitor (BIS)	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.
Optimized general anesthesia care	BP management	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.
Optimized general anesthesia care	General anesthesia	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.
Optimized general anesthesia care	sevoflurane	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	General anesthesia	Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
Usual general anesthesia care	sevoflurane	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	propofol	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.
Optimized general anesthesia care	fentanyl	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	fentanyl	Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
Mini Mental State Exam	propofol	Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
Mini Mental State Exam	sevoflurane	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	fentanyl	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	sevoflurane	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	propofol	Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane

Primary Outcome Measures

Name	Time	Method
Severity of Postoperative Delirium	5 postoperative days	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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Experienced Postoperative Complications	3 months and 1 year	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 of Patients Who Presented With Postoperative Delirium	5 postoperative days	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.
Perioperative Inflammatory Response	preoperative, day of surgery, and postoperative day 2	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.