NCT00250237

Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery

Randomised Double-blind Placebo-controlled Study of Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Bronovo Hospital · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Post-Operative Delirium
• Hip Fracture

Interventions

Type	Name	Description
DRUG	Haloperidol	Haloperidol 1mg twice daily during 72hours
DRUG	placebo	Placebo 1mg twice daily during 72hours

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-11-01
• Completion: 2009-02-01
• First posted: 2005-11-08
• Last updated: 2009-08-07

Locations

1 site across 1 country: Netherlands