Does Optimized General Anesthesia Care Reduce Postoperative Delirium?
NCT02604459 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145
Last updated 2023-10-17
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.
Conditions
- Hip Fractures
- Anesthesia
- Delirium
Interventions
- 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 per protocol
- DRUG
-
sevoflurane
maintenance of anesthesia with inhaled sevoflurane
Sponsors & Collaborators
-
University of Missouri-Columbia
lead OTHER
Principal Investigators
-
Quinn L Johnson, MD · University of Missouri-Columbia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-06-01
- Primary Completion
- 2018-02-28
- Completion
- 2018-02-28
Countries
- United States
Study Locations
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