Namenda to Prevent Post-Operative Delirium

NCT00303433 | Terminated Phase 4

• 2 other identifiers: RSRB-00012460NAM-MD-35
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Post-Operative States

Keywords

Prevention; Post-Operative tates; Delirium; Namenda

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

Interventions

Namenda DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Forest Laboratories: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

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MeSH Terms

Conditions

Delirium

Interventions

Memantine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Michael R Privitera, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 14, 2006
• First Posted: March 16, 2006
• Study Start: March 1, 2006
• Study Completion: September 1, 2006
• Last Updated: June 3, 2015

Record last verified: 2009-12

Locations

US (1)