NCT00835159

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

February 13, 2014

Completed
Last Updated

February 9, 2015

Status Verified

January 1, 2015

Enrollment Period

1.6 years

First QC Date

February 2, 2009

Results QC Date

April 12, 2013

Last Update Submit

January 26, 2015

Conditions

DeliriumPostoperative Cognitive Dysfunction

Keywords

Postoperative DeliriumPostoperative Cognitive DysfunctionRivastigmineExelonMemory impairmentDeliriumCognitive function

Outcome Measures

Primary Outcomes (1)

  • Incidence of POD

    Is the incidence of POD not affected by rivastigmine treatment or not.

    72 hours postoperatively

Study Arms (2)

Rivastigmine Patch

EXPERIMENTAL

Group receiving Rivastigmine Patch

Drug: Rivastigmine Patch

Placebo Patch

PLACEBO COMPARATOR

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

Interventions

Rivastigmine PatchDRUG

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

Also known as: Exelon Patch
Rivastigmine Patch
Placebo PatchOTHER

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

Placebo Patch

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Medical Center, Department of Anesthesiology 550 First Avenue, RR-603

New York, New York, 10016, United States

Location

Related Publications (1)

  • Zaslavsky A, Haile M, Kline R, Iospa A, Frempong-Boadu A, Bekker A. Rivastigmine in the treatment of postoperative delirium: a pilot clinical trial. Int J Geriatr Psychiatry. 2012 Sep;27(9):986-8. doi: 10.1002/gps.2801. No abstract available.

    PMID: 22886871RESULT

MeSH Terms

Conditions

DeliriumPostoperative Cognitive ComplicationsEmergence DeliriumMemory Disorders

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersPostoperative ComplicationsPathologic ProcessesCognitive DysfunctionCognition Disorders

Limitations and Caveats

The study was halted prematurely because of a warning letter issued by the rivastigmine manufacturer indicating the possibility of increased mortality associated with the oral administration of the drug in critically ill patients.

Results Point of Contact

Title
ALEXANDER ZASLAVSKY
Organization
NYU Langone Medical Center
michael.haile@nyumc.org
212-263-5569

Study Officials

  • Alex Bekker, MD, PhD

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 3, 2009

Study Start

December 1, 2008

Primary Completion

July 1, 2010

Study Completion

October 1, 2010

Last Updated

February 9, 2015

Results First Posted

February 13, 2014

Record last verified: 2015-01

Locations

US(1)