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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00257868
Date of registration: 22/11/2005
Prospective Registration: Yes
Primary sponsor: University Hospital, Basel, Switzerland
Public title: Rivastigmine for the Prevention of Postoperative Delirium in Patients Undergoing Cardiac Surgery
Scientific title: Rivastigmine for the Prevention of Postoperative Delirium After Cardiac Surgery
Date of first enrolment: January 2006
Target sample size: 120
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00257868
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention  
Phase:  Phase 3
Countries of recruitment
Switzerland
Contacts
Name:     Luzius A Steiner, MD PhD
Address: 
Telephone:
Email:
Affiliation:  Department of Anaesthesia, University Hospital Basel, Switzerland
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients undergoing cardiac surgery with use of extracorporeal circulation

- Aged 65 or more

Exclusion Criteria:

- "redo" procedures

- anticipated use of succinylcholine during operation

- contraindications to rivastigmine

- preoperative mini mental score < 15



Age minimum: 65 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Delirium
Intervention(s)
Drug: Rivastigmine prevention of delirium
Primary Outcome(s)
Development of postoperative delirium within 7 days after cardiac surgery
Secondary Outcome(s)
Length of stay (intensive care and hospital)
Severity of delirium occurring within 7 days after cardiac surgery
Amount of drugs used for rescue therapy of delirium
Secondary ID(s)
CENA713CCH01
EKBB 204/05
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Novartis
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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