Columbia, Missouri 65203


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT02604459


Primary Contact:

Principal Investigator
Terri G Monk, MD
University of Missouri-Columbia

Terri G Monk, MD
Phone: 5738822568
Email: monkt@health.missouri.edu


Backup Contact:

Email: zinoa@health.missouri.edu
Adam Zino, MPh
Phone: 57388222568


Location Contact:

Columbia, Missouri 65203
United States

Terri G Monk, MD
Phone: 573-882-2568
Email: monkt@health.missouri.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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