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Prevention of postoperative delirium with donepezil

Conditions
Postoperative delirium
Registration Number
EUCTR2006-004434-32-DE
Lead Sponsor
Technische Universität München, Fakultät für Medizin, Klinikum rechts der Isar
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
400
Inclusion Criteria

Patients who are 70 years and older, who are admitted for elective hip or knee joint replacement
ASA-classification I - III
Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Evidence of delirium
Sensory impairment
Hypersensitivity to donepezilhydrochlorid (DPZ) or piperidine derivates or contraindications to the use of DPZ
bradycardia
asthma
COPD
gastric ulcer
participation in a clinical trial

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: To investigate, if perioperative treatment with donepezil reduces the incidence of postoperative delirium in patients older than 69 years with elective knee- or hip joint replacement.;Secondary Objective: To investigate, if perioperative treatment with donepezil influences<br>- severity and duration of postoperative delirium<br>- degree and duration of postoperative delirium<br>- length of hospital stay<br>- management of general anaesthesia;Primary end point(s): Incidence of postoperative delirium accotding to CAM (Confusion assessment method) criteria
Secondary Outcome Measures
NameTimeMethod
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