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Zolpidem for Delirium Prevention in Hip Fracture
NCT00286936Phase 4
Key facts
- Status
- Terminated
- Start
- Feb 2004
- Countries
- 1
- Sponsor
- Copenhagen University Hospital - Hvidovre
- Modality
- Small Molecules
- Drugs
- zolpidem
- Conditions
- delirium
01
Overview
Phase 4, randomised, double-blind trial in delirium comparing Zolpidem with Placebo (2 arms). Primary endpoint: Incidence and severity of postoperative delirium. Started Feb 2004; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Zolpidem
Zolpidem 5 mg daily
Placebo
Placebo daily
03
Who it enrols
Patients with primary hip fracture, aged 70 years or older, without substance abuse, regular opioid/corticosteroid/benzodiazepine therapy, hepatic insufficiency, myasthenia gravis, or severe respiratory insufficiency.
04
Endpoints
Primary
Incidence and severity of postoperative delirium
Secondary
Sleep quality
mobilization
loss of functional ability
length of stay
sedation
nocturnal nursing events
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