Does Optimized General Anesthesia Care Reduce Postoperative Delirium? (OPCare)

University of Missouri (MU)

Status: Terminated

Conditions: Hip Fractures; Delirium; Anesthesia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02604459

1212915

Details and patient eligibility

About

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.

Full 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.

Enrollment: 145 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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145 participants in 4 patient groups

Usual general anesthesia care

Active Comparator group

Description:

Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane

Treatment:

Drug: sevoflurane

Procedure: General anesthesia

Drug: fentanyl

Drug: propofol

Optimized general anesthesia care

Experimental group

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.

Treatment:

Drug: sevoflurane

Procedure: General anesthesia

Procedure: BP management

Drug: fentanyl

Device: depth of anesthesia monitor (BIS)

Drug: propofol

Device: cerebral oximeter (Fore-Sight)

Mini Mental State Exam

Active Comparator group

Description:

Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane

Treatment:

Drug: sevoflurane

Procedure: General anesthesia

Drug: fentanyl

Drug: propofol

Tested and Excluded

Other group

Description:

Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane

Treatment:

Drug: sevoflurane

Procedure: General anesthesia

Drug: fentanyl

Drug: propofol