N/A
N=12
A Trial To Assess Risk of Delirium in Older Adults Undergoing Hip Fracture Surgery With Spinal or General Anesthesia
Postoperative Complications · Hip Fracture · Delirium
Bottom Line
View on ClinicalTrials.gov: NCT02190903 ↗Enrolled (actual)
12
Serious AEs
8.3%
Results posted
Jul 2018
Primary outcome: Primary: Number of Participants With Postoperative Delirium After Hip Fracture Surgery — 2; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- General endotracheal anesthesia (Other); Regional (spinal) Anesthesia (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Postoperative Delirium After Hip Fracture Surgery |
2; 0 | — |
Summary
This pilot project will address the gaps in knowledge regarding the effect of anesthetic technique on the risk of delirium through an adequately-powered trial employing standardized regimens for treatment and outcome assessment to test the hypothesis that use of spinal versus general anesthesia decreases the risk of delirium after hip fracture surgery.
Eligibility Criteria
Inclusion Criteria
- Subject is aged 18 and older.
- Subject is scheduled to undergo surgical treatment of an acute femoral neck or pertrochanteric hip fracture.
- Subject can speak English
- Subject has ability to sign informed consent
Exclusion Criteria
- Subject has a pathological or periprosthetic fracture.
- Subject has concurrent conditions anticipated at the time of admission to require surgical treatment (e.g. multiple trauma, acute cholecystitis).
- Subject has severe cognitive impairment, as evidenced by a Montreal Cognitive Assessment Score (MOCA) of 15 or less.
- Subject has clinical findings of delirium prior to surgery, as evidenced by a positive Confusion Assessment Method (CAM) evaluation;
- Subject has contraindications to spinal anesthesia or volatile general anesthetics.
Data sourced from ClinicalTrials.gov (NCT02190903). 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.