Namenda to Prevent Post-Operative Delirium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00303433
Recruitment Status : Terminated
First Posted : March 16, 2006
Last Update Posted : June 3, 2015
Forest Laboratories
Information provided by:
University of Rochester

Brief Summary:

Post Operative Delirium is a common and serious risk of surgery. Delirium, when it occurs is associated with an increased risk of mortality, increase length of stay, and more adverse outcomes in general, including increased risk of higher level of care required at discharge.

Namenda, which is currently approved for moderate or severe Alzheimer's disease has a unique mechanism of action than other drugs for this condition. It may have the ability to protect the brain from more severe consequences of hypoxia, or hypoglycemia. Hence it is being looked at in this study to see if it can reduce the incidence and/or severity of delirium post-operatively.

Condition or disease Intervention/treatment Phase
Delirium Post-Operative States Drug: Namenda Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Namenda as Prevention for Post-Operative Delirium
Study Start Date : March 2006
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
U.S. FDA Resources

Primary Outcome Measures :
  1. Incidence and severity of delirium measured by Delirium Rating Scale-Revised-98, MMSE. Confusion Assessment Method, Clock Drawing Tests (CLOX), DSM-IV-TR criteria for Delirium.

Secondary Outcome Measures :
  1. Length and cost of stay, disposition, level of care required post hosptialization, hospitalization satisfaction, number of consultants involved, total costs of care.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Medically stable
  • 50 years of age or older
  • having elective joint replacement surgery or other orthopedic procedures that are major surgery and require general anesthesia.

Exclusion Criteria:

  • Alcohol or sedative hypnotic abuse or dependence
  • Pregnancy
  • Dementia or MR/DD patients if they do not have sufficient capacity to understand the consent
  • renal impairment or a creatinine of 1.4 or higher
  • currently taking cholinesterase inhibitors.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00303433

United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Forest Laboratories
Principal Investigator: Michael R Privitera, MD University of Rochester

Foreman MD. Prevention and Treatment Strategies for Delirium. Primary Psychiatry 11(11): 52-58, 2004.
Potkin et al Abstract LBS.003 American Academy of Neurology 56th annual meeting April 24-May 1 2004, San Francisco California.
Diagnostic and Statistical Manual of Mental Disorders, Forth Edition, Text Revision. Washington D.C., American Psychiatric Association, 2000.
Cohen J. Statistical Power Analysis for the Behavioral Sciences, 2nd ed. Lawrence Erlbaum Associates, New Jersey. Identifier: NCT00303433     History of Changes
Obsolete Identifiers: NCT00303095
Other Study ID Numbers: RSRB-00012460
First Posted: March 16, 2006    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: December 2009

Keywords provided by University of Rochester:
Post-Operative tates

Additional relevant MeSH terms:
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents