N/A
Completed N=200
Post-Operative Delirium in Elderly Surgical Patients
Source: ClinicalTrials.gov NCT00590707 ↗Enrolled (actual)
200
Serious AEs
14.5%
Results posted
Jun 2018
Primary outcomePrimary: Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method — 39; 34 Participants
Summary
This research is being done to see what effects sedative drugs during surgery have on peoples' thinking processes after they wake up.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method |
39; 34 | — |
| SECONDARY Change in Functional Status |
4.2; 4.1 | — |
| SECONDARY Mortality |
14; 14 | — |
| SECONDARY Number of Participants With the Presence of Delirium at 1 Month as Assessed by the Confusion Assessment Method |
3; 1 | — |
| SECONDARY Clinical Dementia Rating Sum of Boxes (CDR-SOB) Score |
2.0; 2.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00590707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.