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

This study has been completed.
Sponsor:
Information provided by:
Bronovo Hospital
ClinicalTrials.gov Identifier:
NCT00250237
First received: November 7, 2005
Last updated: August 6, 2009
Last verified: August 2009
History of Changes

November 7, 2005
August 6, 2009
November 2005
November 2008   (final data collection date for primary outcome measure)
Incidence of post-operative delirium [ Time Frame: 72 hours post surgery ] [ Designated as safety issue: No ]
Incidence of post-operative delirium
Complete list of historical versions of study NCT00250237 on ClinicalTrials.gov Archive Site
  • Length of stay [ Time Frame: days ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]
  • Length of stay.
  • Mortality.
  • ADL dependence at 3 months.
Not Provided
Not Provided
 
Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery
Randomised Double-blind Placebo-controlled Study of 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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Post-Operative Delirium
  • Hip Fracture
  • Drug: Haloperidol
    Haloperidol 1mg twice daily during 72hours
  • Drug: placebo
    Placebo 1mg twice daily during 72hours
  • Active Comparator: A
    Patients receiving blinded medication (Haloperidol or Placebo)
    Intervention: Drug: Haloperidol
  • Placebo Comparator: B
    Patients receiving blinded medication (Haloperidol or Placebo)
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
February 2009
November 2008   (final data collection date for primary outcome measure)

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
Both
75 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00250237
05-56
Yes
Department of Surgery, Bronovo Hospital
Bronovo Hospital
Not Provided
Principal Investigator: Boke Linso Sjirk Borger van der Burg, MD Bronovo Hospital
Bronovo Hospital
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP