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NCT Number: NCT00250237

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

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.

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Key information

Conditions

Post-operative Delirium Confusion Delirium Emergence Delirium Femoral Fractures Fractures, Bone Hip Fracture Hip Fractures Hip Injuries Leg Injuries Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bronovo Hospital

The Hague, South Holland, 2597 AX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Haloperidol

Drug

Haloperidol 1mg twice daily during 72hours

Placebo

Drug

Placebo 1mg twice daily during 72hours

Primary outcomes

  1. Incidence of post-operative delirium

    Time frame: 72 hours post surgery

Secondary outcomes

  1. Length of stay

    Time frame: days

  2. Complications

    Time frame: during hospitalization

Sponsors and collaborators

Lead sponsor

Bronovo Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Nov 8, 2005
Registry last updated
Aug 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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