Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery
Phase 3
Completed
- Conditions
- Post-Operative DeliriumHip Fracture
- Interventions
- Drug: placebo
- Registration Number
- NCT00250237
- Lead Sponsor
- Bronovo Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description B placebo Patients receiving blinded medication (Haloperidol or Placebo) A Haloperidol Patients receiving blinded medication (Haloperidol or Placebo)
- Primary Outcome Measures
Name Time Method Incidence of post-operative delirium 72 hours post surgery
- Secondary Outcome Measures
Name Time Method Length of stay days Complications during hospitalization
Trial Locations
- Locations (1)
Bronovo Hospital
🇳🇱The Hague, Zuid Holland, Netherlands