Post-operative delirium. MedDRA version: 9.1 Level: LLT Classification code 10012218 Term: Delirium
Conditions
Interventions
Trade Name: Aricept
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placeb
Sponsors
Stanmore Clinical Research Facility Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: • Awaiting elective total hip or knee replacement • 65 years old or over • Valid written 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
Exclusion criteria: Exclusion criteria: • Subjects with delirium as defined by the CAM • Subjects undergoing revision/complex hip/knee surgery • Subjects who are deaf, visually impaired or have insufficient English to the extent where they cannot complete the study assessments. • Subjects with moderately severe cognitive impairment at baseline (i.e. MMSE <20) • Subjects with alcohol dependence syndrome (ICD-10 definition) • Subjects with severe nausea and vomiting precluding the use of DPZ • Subjects currently taking cholinesterase inhibitors • Subjects taking antipsychotic/ neuroleptic medication that may mask symptoms of delirium • Hypnotics or anxiolytics initiated less than a month ago • Subjects with a known hypersensitivity to DPZ (piperidine derivatives or any excipients used in its formulation – or that of the placebo) • Severe bladder outflow obstruction Spinal anaesthesia during surgery • Subjects with cardiac problems that contraindicate the prescription of cholinesterase inhibitors: o Sick sinus syndrome o Resting pulse of <50 o Supraventricular conduction defects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether patients who are treated with 5 mg of donepezil (DPZ) for 7 days after an elective total hip or knee replacement show a reduced incidence of delirium.; Secondary Objective: To determine whether: a) Patients who are treated with 5 mg of DPZ for 7 days after an elective total hip or knee replacement will show a reduction in the severity of delirium. b) Patients who are treated with 5 mg of DPZ for 7 days after an elective total hip or knee replacement will show a decrease in the duration of delirium. c) Patients who are treated with 5 mg of DPZ for 7 days after an elective total hip or knee replacement will show a reduction in subsyndromal symptoms and behavioural symptoms associated with delirium. d) Patients who are treated with 5 mg of DPZ for 7 days after an elective total hip or knee replacement will show less worsening in cognitive functions in both the short and long term. e) Patients who are treated with 5 mg of DPZ for 7 days after an elective total hip or knee replacement will show a reduction in hospital stay. ; Primary end point(s): The primary endpoint of the study will be the incidence of post-operative delirium. Patients will be considered as a case of delirium if at any point during the course of follow up (to Day 7) they develop an episode of delirium. A risk ratio will be calculated. Delirium will be diagnosed using the Confusion Assessment Method (CAM) (Inouye et al. 1990), as the primary outcome variable. This is the most widely used instrument for the detection of delirium in the acute hospital setting. It has a sensitivity of 94-100% and a specificity of 90-95% and generates a DSM IV diagnosis of delirium. | — |
Countries
United Kingdom
Outcome results
None listed