Namenda to Prevent Post-Operative Delirium

This study has been terminated.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00303433
First received: March 14, 2006
Last updated: December 9, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Delirium
Post-Operative States
Drug: Namenda
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Namenda as Prevention for Post-Operative Delirium

Resource links provided by NLM:


Further study details as provided by University of Rochester:

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

Estimated Enrollment: 30
Study Start Date: March 2006
Estimated Study Completion Date: September 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303433

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

Publications:
Bekker AY. Cognitive Function after Anesthesia in the Elderly. Best Practice and Research 17(2): 259-272, 2003.
Inouye SK, Gen Intern Med 13: 234-242, 1998.
McCuster J. Arch Intern Med 162, Feb 25:457-463,2002.
Inouye SK. Geriatric Psychiatry Neurol 11: 118-125, 1998.
Breitbart W, Gibson C, Tremblay A. Psychosomatics 43: 183-194, 2002.
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.
Cepeda C. Dev Neuroscience 20:1-18, 1998.
Cepeda C. Eur J Neurosci 10:3491-3497, 1998.
Huang KX. Synapse 30:18-29,1998.
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.

ClinicalTrials.gov Identifier: NCT00303433     History of Changes
Obsolete Identifiers: NCT00303095
Other Study ID Numbers: RSRB-00012460, NAM-MD-35
Study First Received: March 14, 2006
Last Updated: December 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
Prevention
Post-Operative tates
Delirium
Namenda

Additional relevant MeSH terms:
Delirium
Confusion
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Memantine
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014