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

Hip Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250237
• Other study ID #: 05-56
• Status: Completed
• Phase: Phase 3
• First received: November 7, 2005
• Last updated: August 6, 2009
• Start date: November 2005
• Est. completion date: February 2009

Study information

• Verified date: August 2009
• Source: Bronovo Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: February 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Delirium
• Hip Fracture
• Hip Fractures
• Post-Operative Delirium

Intervention

Drug:
• Haloperidol
Haloperidol 1mg twice daily during 72hours
• placebo
Placebo 1mg twice daily during 72hours

Locations

Country	Name	City	State
Netherlands	Bronovo Hospital	The Hague	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Bronovo Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post-operative delirium		72 hours post surgery	No
Secondary	Length of stay		days	No
Secondary	Complications		during hospitalization	Yes