A Phase 3 interventional study of Haloperidol and placebo in Post-Operative Delirium and Hip Fracture, sponsored by Bronovo Hospital. Completed at 1 site in Netherlands. Open to participants aged 75 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-08-07.
Sponsored by Bronovo Hospital · Phase 3, Interventional, and Prevention
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.
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.
788 studies on the registry are indexed under Emergence Delirium; 250 are open to participants now.
This study's enrollment of 220 is above the median of 120 across 491 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →This is the only study on the registry with Bronovo Hospital as lead sponsor.
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Exclusion Criteria:
Patients receiving blinded medication (Haloperidol or Placebo)
Drug: Haloperidol
Patients receiving blinded medication (Haloperidol or Placebo)
Drug: placebo
Haloperidol 1mg twice daily during 72hours
Placebo 1mg twice daily during 72hours
Incidence of post-operative delirium
Time frame: 72 hours post surgery
Length of stay
Time frame: days
Complications
Time frame: during hospitalization
This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Haloperidol