Clinical trial

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

Name
1212915
Description
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.
Trial arms
Trial start
2015-06-01
Estimated PCD
2018-02-28
Trial end
2018-02-28
Status
Terminated
Treatment
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.
Arms:
Optimized general anesthesia care
depth of anesthesia monitor (BIS)
The depth of anesthesia will be maintained between 40 and 60 in the optimized care group.
Arms:
Optimized general anesthesia care
BP management
The systolic blood pressure will be maintained within 20% of preoperative levels in the optimized care group.
Arms:
Optimized general anesthesia care
General anesthesia
General anesthesia will be used in both groups
Arms:
Mini Mental State Exam, Optimized general anesthesia care, Tested and Excluded, Usual general anesthesia care
propofol
propofol per protocol
Arms:
Mini Mental State Exam, Optimized general anesthesia care, Tested and Excluded, Usual general anesthesia care
Other names:
diprivan
fentanyl
fentanyl per protocol
Arms:
Mini Mental State Exam, Optimized general anesthesia care, Tested and Excluded, Usual general anesthesia care
Other names:
sublimaze
sevoflurane
maintenance of anesthesia with inhaled sevoflurane
Arms:
Mini Mental State Exam, Optimized general anesthesia care, Tested and Excluded, Usual general anesthesia care
Other names:
ultane
Size
145
Primary endpoint
Severity of Postoperative Delirium
5 postoperative days
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The individuals assessing the patients for delirium after surgery will be unaware of the treatment in the operating room.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 145, 'type': 'ACTUAL'}}
Updated at
2023-10-17

1 organization

2 products

1 drug

3 indications

Product
propofol
Indication
Hip Fractures
Indication
Anesthesia
Indication
Delirium