A Strategy to Reduce the Incidence of Post-Operative Delirium in Elderly Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hip Fractures
- Sponsor
- Johns Hopkins University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This research is being done to see what effects sedative drugs during surgery have on peoples' thinking processes after they wake up.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method
Time Frame: Postoperative days up to hospital discharge
The presence of delirium is assessed by the confusion assessment method (CAM), during postoperative Day 1 to Day 5 or up to hospital discharge, whichever occurs first. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.
Secondary Outcomes
- Mortality(12 months post-operative)
- Change in Functional Status(12 months post-operative)
- Clinical Dementia Rating Sum of Boxes (CDR-SOB) Score(12 months post-operative)
- Number of Participants With the Presence of Delirium at 1 Month as Assessed by the Confusion Assessment Method(1 month (30 days) post-intervention)