Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu

Rivastigmine in the Treatment of Postoperative Delirium: a Pilot Clinical Trial

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: NCT00835159
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : February 13, 2014
Last Update Posted : February 9, 2015
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The purpose of this study is to determine whether preoperative administration of Rivastigmine prevents the incidence of postoperative delirium in patients undergoing major surgery as well as postoperative cognitive dysfunction.

Condition or disease Intervention/treatment Phase
Delirium Postoperative Cognitive Dysfunction Drug: Rivastigmine Patch Other: Placebo Patch Phase 4

Detailed Description:
Postoperative delirium (POD) and Postoperative cognitive dysfunction (POCD) are common significant postoperative complications in elderly patients. A reduction of postoperative complications would lead to improved functional status, greater independence and reduction in health care cost. Scientific evidence shows that acetylcholinesterase inhibitors may reduce incidence and/or severity of postoperative delirium. We propose to conduct a randomized, double-masked, placebo-controlled study to assess effectiveness of Rivastigmine, an acetylcholinesterase inhibitor. Rivastigmine transdermal system (Exelon Patch) is approved by FDA for the treatment of mild to moderate Alzheimer's dementia and mild to moderate dementia associated with Parkinson's disease. Patients 65 y.o. and older undergoing major elective surgery will qualify for the study based on risk assessment guidelines. Patients screening will include Mini Mental Status Examination (MMSE to assess baseline cognitive function), Hamilton scale (to screen for depression), Telephone Interview of Cognitive Status Modified (TICS-M to assess baseline cognitive function over the phone) and Brief Test of Adult Cognition by Telephone (BTACT to assess baseline cognitive function over the phone). All study subjects will be randomly assigned to one of 2 groups prior to surgery. The treatment group will receive a Rivastigmine patch preoperatively covered by tegaderm dressing and a placebo group will receive just a tegaderm dressing. Both groups will be assessed twice daily at 9am and 4pm for up to 72 hours postoperatively with Confusion Assessment Method for Intensive Care Unit (CAM-ICU), Memorial Delirium Assessment Scale (MDAS) and Mini Mental Status Examination (to diagnose delirium and assess its severity). At one month and three months postoperatively subjects with a postoperative MMSE of 27 or less will be assessed for postoperative cognitive dysfunction. The assessment will be performed over the phone with TICS-M and Brief Test of Adult Cognition by Telephone. Outcomes will be divided into Primary and Secondary outcomes. Primary outcome will determine the proportions of patients with at least one episode of POD in the treatment and placebo groups, diagnosed by CAM-ICU. Secondary outcome will determine the proportions of patients with development of POCD in both groups, diagnosed by TICS-M at 1 month postoperatively. Secondary outcome will also determine cumulative number of POD episodes within first 3 days of hospital stay as diagnosed by CAM-ICU, severity of POD as diagnosed by the MDAS, recovery of cognitive function as diagnosed by MMSE, TICS-M and BTACT, and length of hospital stay.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Rivastigmine in the Treatment of Postoperative Delirium: a Pilot Clinical Trial
Study Start Date : December 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Rivastigmine Patch
Group receiving Rivastigmine Patch
Drug: Rivastigmine Patch
Rivastigmine Patch 4.6 mg/24 hours: 5 cm2 size containing 9 mg rivastigmine applied to upper back preoperatively for a period of 24 hours
Other Name: Exelon Patch

Placebo Comparator: Placebo Patch
A 2x2 gauze and a Tegaderm dressing applied to upper back within 3 hours of surgery for a period of 24 hours.
Other: Placebo Patch
A 2x2 gauze and a Tegaderm dressing applied to upper back within 3 hours of surgery for a period of 24 hours.

Primary Outcome Measures :
  1. Incidence of POD [ Time Frame: 72 hours postoperatively ]
    Is the incidence of POD not affected by rivastigmine treatment or not.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

65 ≥ y.o. undergoing major elective surgery over 2 hours in length with one or more of the following:

  • Preoperative cognitive impairment
  • Age > 70 y.o.
  • Use of psychoactive medications
  • History of prior delirium
  • Severe illness/co-morbidity

Exclusion Criteria:

  • Delirium on admission Profound dementia No spoken/written English An emergent procedure Hypersensitivity to Rivastigmine

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): NCT00835159

Layout table for location information
United States, New York
NYU Langone Medical Center, Department of Anesthesiology 550 First Avenue, RR-603
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Layout table for investigator information
Principal Investigator: Alex Bekker, MD, PhD NYU School of Medicine
Publications of Results:
Layout table for additonal information
Responsible Party: NYU Langone Health Identifier: NCT00835159    
Other Study ID Numbers: H# 08-765
First Posted: February 3, 2009    Key Record Dates
Results First Posted: February 13, 2014
Last Update Posted: February 9, 2015
Last Verified: January 2015
Keywords provided by NYU Langone Health:
Postoperative Delirium
Postoperative Cognitive Dysfunction
Memory impairment
Cognitive function
Additional relevant MeSH terms:
Layout table for MeSH terms
Emergence Delirium
Postoperative Cognitive Complications
Cognitive Dysfunction
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Postoperative Complications
Pathologic Processes
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents