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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00835159
First received: February 2, 2009
Last updated: February 12, 2014
Last verified: February 2014
Results First Received: April 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Delirium
Postoperative Cognitive Dysfunction
Interventions: Drug: Rivastigmine Patch
Other: Placebo Patch

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patientsof 65years and older admitted for elective surgery undergeneral anesthesia were screened. Only patients at risk fordeveloping POD were considered for recruitment

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a randomized, placebo controlled, double-blind clinical trial. Screened patients were 65 years +, having elective surgery under general anesthesia. Only patients at risk for POD were considered for recruitment. Eligible patients received rivastigmine 5cm2 transdermal or placebo patch. 30 patients recruited but only 28 had complete data.

Reporting Groups
  Description
Rivastigmine 5-cm2 Transdermal Patch Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch
Placebo Patch Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.

Participant Flow:   Overall Study
    Rivastigmine 5-cm2 Transdermal Patch     Placebo Patch  
STARTED     11     17  
COMPLETED     11     17  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rivastigmine 5-cm2 Transdermal Patch Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch
Placebo Patch Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.
Total Total of all reporting groups

Baseline Measures
    Rivastigmine 5-cm2 Transdermal Patch     Placebo Patch     Total  
Number of Participants  
[units: participants]
  11     17     28  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     11     17     28  
Age  
[units: years]
Mean ± Standard Deviation
  72.0909  ± 5.55796     72.6471  ± 6.52822     72.4286  ± 6.06403  
Gender  
[units: participants]
     
Female     6     10     16  
Male     5     7     12  
Region of Enrollment  
[units: participants]
     
United States     11     17     28  



  Outcome Measures

1.  Primary:   Incidence of POD   [ Time Frame: 72 hours postoperatively ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: ALEXANDER ZASLAVSKY
Organization: NYU Langone Medical Center
phone: 212-263-5569
e-mail: michael.haile@nyumc.org


Publications of Results:

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00835159     History of Changes
Other Study ID Numbers: H# 08-765
Study First Received: February 2, 2009
Results First Received: April 12, 2013
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board