Post-Operative Delirium in Elderly Surgical Patients
This trial is active, not recruiting.
|Conditions||hip fractures, delirium|
|Treatments||deeper sedation, moderate sedation|
|Sponsor||Johns Hopkins University|
|Collaborator||National Institute on Aging (NIA)|
|Start date||January 2005|
|End date||May 2017|
|Trial size||200 participants|
|Trial identifier||NCT00590707, ACCM Delirium 3, NA_00041873, R01AG033615|
This research is being done to see what effects sedative drugs during surgery have on peoples' thinking processes after they wake up.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, outcomes assessor)|
Presence of delirium
time frame: Postoperative days 1-5; 1 mon. after surgery; & 1 yr. after surgery
Change in functional status
time frame: 1 mon. & 1 yr. after surgery
Male or female participants at least 65 years old.
Inclusion Criteria: - is 65 years of age or older at admission; - has surgical treatment of a traumatic hip fracture; - has participating surgeon; - has Mini-Mental Status Exam score of 15 or higher; - able to read/write/speak/hear/understand English; - gives informed consent; - receives spinal anesthesia Exclusion Criteria: - receives general anesthesia; - does not write/write/speak/hear/understand English; - has severe chronic obstructive pulmonary disease (COPD); - has severe congestive heart failure (CHF); - has Mini-Mental Status Exam score less than 15; - declines to give informed consent; - age less than 65 years at admission; - attending surgeon does not participate in study
|Official title||A Strategy to Reduce the Incidence of Post-Operative Delirium in Elderly Patients|
|Principal investigator||Frederick E. Sieber, MD|
|Description||We give sedative drugs to patients having spinal anesthesia so they are "asleep" (sedated) while we are fixing their broken hips. The spinal anesthesia provides pain relief at the site of surgery, while the sedative drugs keep people "asleep" during the procedure. We want to find out whether the amount of sedation we give might (1) make patients be confused when they wake up or (2) have anything to do with how well patients can do their ordinary daily routines a few months after their surgery.|
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