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

Bronovo Hospital

Status and phase: Completed; Phase 3

Conditions: Post-Operative Delirium; Hip Fracture

Treatments: Drug: Haloperidol; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00250237

05-56

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 75+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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220 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

Patients receiving blinded medication (Haloperidol or Placebo)

Treatment:

Drug: Haloperidol

B

Placebo Comparator group

Description:

Patients receiving blinded medication (Haloperidol or Placebo)

Treatment:

Drug: placebo