Hip Fracture, Post-Operative Delirium
Conditions
Keywords
Post-operative delirium, hip fracture
Brief summary
In this study the investigators want to determine if treatment with haloperidol direct post-operatively after acute hip surgery in high risk patients protects against developing a post-operative delirium.
Detailed description
A post-operative delirium is a serious and frequent (35-65%) complication with high morbidity and mortality in high risk patients. In this study we investigate whether we can prevent a delirium from occuring after surgery in patients with a hip fracture of 75 years of age and older. It's a randomised double-blind single centre placebo-controlled study of haloperidol versus placebo.
Interventions
DRUGHaloperidol
Haloperidol 1mg twice daily during 72hours
DRUGplacebo
Placebo 1mg twice daily during 72hours
Sponsors
Bronovo Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Hip fracture * 75 years and older
Exclusion criteria
* Contra-indications for the use of haloperidol * Pre-operative delirium * Pre-operative use of haloperidol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of post-operative delirium | 72 hours post surgery |
Secondary
| Measure | Time frame |
|---|---|
| Length of stay | days |
| Complications | during hospitalization |
Countries
Netherlands
Outcome results
None listed