Namenda to Prevent Post-Operative Delirium - Full Text View

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:

MedlinePlus related topics: Delirium

Drug Information available for: Memantine Memantine hydrochloride

U.S. FDA Resources

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

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:

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Breitbart W, Rosenfeld B, Roth A, Smith MJ, Cohen K, Passik S. The Memorial Delirium Assessment Scale. J Pain Symptom Manage. 1997 Mar;13(3):128-37.

Bekker AY. Cognitive Function after Anesthesia in the Elderly. Best Practice and Research 17(2): 259-272, 2003.

Nishikawa K, Nakayama M, Omote K, Namiki A. Recovery characteristics and post-operative delirium after long-duration laparoscope-assisted surgery in elderly patients: propofol-based vs. sevoflurane-based anesthesia. Acta Anaesthesiol Scand. 2004 Feb;48(2):162-8.

Inouye SK. Delirium in hospitalized elderly patients: recognition, evaluation, and management. Conn Med. 1993 May;57(5):309-15. Review. No abstract available.

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.

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Saravay SM, Strain JJ. APM Task Force on Funding Implications of Consultation-Liaison Outcome Studies. Special series introduction: a review of outcome studies. Psychosomatics. 1994 May-Jun;35(3):227-32. No abstract available.

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Schor JD, Levkoff SE, Lipsitz LA, Reilly CH, Cleary PD, Rowe JW, Evans DA. Risk factors for delirium in hospitalized elderly. JAMA. 1992 Feb 12;267(6):827-31.

Cushman LA. Secondary neuropsychiatric complications in stroke: implications for acute care. Arch Phys Med Rehabil. 1988 Oct;69(10):877-9.

Kishi Y, Iwasaki Y, Takezawa K, Kurosawa H, Endo S. Delirium in critical care unit patients admitted through an emergency room. Gen Hosp Psychiatry. 1995 Sep;17(5):371-9.

Berggren D, Gustafson Y, Eriksson B, Bucht G, Hansson LI, Reiz S, Winblad B. Postoperative confusion after anesthesia in elderly patients with femoral neck fractures. Anesth Analg. 1987 Jun;66(6):497-504.

Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62.

Foreman MD. Prevention and Treatment Strategies for Delirium. Primary Psychiatry 11(11): 52-58, 2004.

Bogardus ST Jr, Desai MM, Williams CS, Leo-Summers L, Acampora D, Inouye SK. The effects of a targeted multicomponent delirium intervention on postdischarge outcomes for hospitalized older adults. Am J Med. 2003 Apr 1;114(5):383-90.

Rizzo JA, Bogardus ST Jr, Leo-Summers L, Williams CS, Acampora D, Inouye SK. Multicomponent targeted intervention to prevent delirium in hospitalized older patients: what is the economic value? Med Care. 2001 Jul;39(7):740-52.

Trzepacz PT. Delirium. Advances in diagnosis, pathophysiology, and treatment. Psychiatr Clin North Am. 1996 Sep;19(3):429-48. Review.

Kawashima T, Yamada S. Delirium caused by donepezil: a case study. J Clin Psychiatry. 2002 Mar;63(3):250-1. No abstract available.

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Gleason OC. Donepezil for postoperative delirium. Psychosomatics. 2003 Sep-Oct;44(5):437-8. No abstract available.

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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
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Memantine
Dopamine Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013