NCT02604459

Does Optimized General Anesthesia Care Reduce Postoperative Delirium?

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Fractures
• Anesthesia
• Delirium

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	depth of anesthesia monitor (BIS)	The depth of anesthesia will be maintained between 40 and 60 in the optimized care group.
PROCEDURE	BP management	The systolic blood pressure will be maintained within 20% of preoperative levels in the optimized care group.
PROCEDURE	General anesthesia	General anesthesia will be used in both groups
DRUG	propofol	propofol per protocol
DRUG	fentanyl	fentanyl per protocol
DRUG	sevoflurane	maintenance of anesthesia with inhaled sevoflurane

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-02-28
• Completion: 2018-02-28
• First posted: 2015-11-13
• Last updated: 2023-10-17
• Results posted: 2023-10-17

Locations

1 site across 1 country: United States