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Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo

H

Hvidovre University Hospital

Status and phase

Terminated
Phase 4

Conditions

Delirium
Hip Fracture

Treatments

Drug: Zolpidem

Study type

Interventional

Funder types

Other

Identifiers

NCT00286936
HHSG-RCT-05

Details and patient eligibility

About

To examine the influence of regular hypnotic therapy on the incidence of delirium after hip fracture surgery

Full description

Delirium is prevalent after hip fracture surgery. Delirium has been linked to postoperative sleep disturbances. Zolpidem is a non-benzodiazepine hypnotic that preserves REM sleep. The present study investigates the incidence of delirium in hip fracture patients randomized to Zolpidem treatment 5 mg vs placebo in the perioperative phase.

Enrollment

96 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Primary hip fracture, no substance abuse, no regular opioid, corticosteroid or benzodiazepine therapy, hepatic insufficiency, myastenia gravis, allergies to drug components

Exclusion criteria

  • Severe respiratory insufficiency

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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