Trial name or title |
Post‐operative delirium in elderly surgical patients (STRIDE) |
Methods |
RCT; double‐blind (subject, caregiver, outcomes assessor); parallel assignment |
Participants |
65 years of age or older at admission; has surgical treatment of a traumatic hip fracture; has Mini‐Mental Status Exam score of 15 or higher; able to read/write/speak/hear/understand English; receives spinal anaesthesia |
Interventions |
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair at a BIS score of 50‐60. This is the "deeper sedation" arm. versus patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair at a BIS score of 70‐80. This is the "moderate sedation" arm |
Outcomes |
Primary outcome measures: Presence of delirium (time frame: postoperative days 1‐5; 1 month after surgery; and 1 year after surgery). Memory/thinking testing
Secondary outcome measures: Change in functional status (time frame: 1 month and 1 year after surgery). Ability to perform Activities of Daily Living; strength and walking testing |
Starting date |
January 2005 |
Contact information |
Frederick E. Sieber, MD: fsieber1@jhmi.edu and Michael D. Sklar, MA: msklar1@jhmi.edu |
Notes |
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