Randomised Double-blind Placebo-controlled Study of Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery
Overview
- Phase
- Phase 3
- Intervention
- Haloperidol
- Conditions
- Post-Operative Delirium
- Sponsor
- Bronovo Hospital
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Incidence of post-operative delirium
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
A
Patients receiving blinded medication (Haloperidol or Placebo)
Intervention: Haloperidol
B
Patients receiving blinded medication (Haloperidol or Placebo)
Intervention: placebo
Outcomes
Primary Outcomes
Incidence of post-operative delirium
Time Frame: 72 hours post surgery
Secondary Outcomes
- Length of stay(days)
- Complications(during hospitalization)