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

Information source: Bronovo Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post-Operative Delirium; Hip Fracture

Intervention: Haloperidol (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bronovo Hospital

Official(s) and/or principal investigator(s):
Boke Linso Sjirk Borger van der Burg, MD, Principal Investigator, Affiliation: Bronovo Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Incidence of post-operative delirium

Secondary outcome:

Length of stay

Complications

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.

Eligibility

Minimum age: 75 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Bronovo Hospital, The Hague, Zuid Holland 2597 AX, Netherlands
Additional Information

Starting date: November 2005
Last updated: August 6, 2009

Page last updated: August 23, 2015

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