NCT00699946

Brief Summary

In this study we wanted to determine if perioperative administration of olanzapine prior to knee or hip replacement surgery in high risk patients would prevent the onset of postoperative delirium.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
495

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2009

Enrollment Period

2.6 years

First QC Date

June 16, 2008

Last Update Submit

January 19, 2009

Conditions

Delirium

Keywords

delirium, atypical antipsychotics, olanzapine, orthopedic

Outcome Measures

Primary Outcomes (1)

  • incidence of delirium

    days in hospital

Secondary Outcomes (1)

  • Complications, length of stay, hospital costs

    days

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: olanzapine

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

olanzapineDRUG

5 mg preoperative and 5mg postoperative prior to discharge to inpatient nursing floor

Also known as: Zyprexa
1
placeboDRUG

placebo administered preoperatively and postoperatively prior to discharge to inpatient nursing floor

2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • High risk for delirium age \> 65 history of delirium medical comorbidities ability to give informed consent

You may not qualify if:

  • Dementia Alcohol abuse Current use of an antipsychotic Allergy to olanzapine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New England Baptist Hospital

Boston, Massachusetts, 02120, United States

Location

Related Publications (1)

  • Larsen KA, Kelly SE, Stern TA, Bode RH Jr, Price LL, Hunter DJ, Gulczynski D, Bierbaum BE, Sweeney GA, Hoikala KA, Cotter JJ, Potter AW. Administration of olanzapine to prevent postoperative delirium in elderly joint-replacement patients: a randomized, controlled trial. Psychosomatics. 2010 Sep-Oct;51(5):409-18. doi: 10.1176/appi.psy.51.5.409.

    PMID: 20833940DERIVED

MeSH Terms

Conditions

Delirium

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Susan Kelly, MD

    New England Baptist Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2008

First Posted

June 18, 2008

Study Start

January 1, 2005

Primary Completion

August 1, 2007

Study Completion

October 1, 2007

Last Updated

January 21, 2009

Record last verified: 2009-01

Locations

US(1)