Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo
To examine the influence of regular hypnotic therapy on the incidence of delirium after hip fracture...
Brief Summary
Official Title: “Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo”
To examine the influence of regular hypnotic therapy on the incidence of delirium after hip fracture surgery
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Zolpidem
Outcome Measures for this Clinical Trial
Primary Measures
- Incidence and severity of postoperative delirium
Secondary Measures
- Sleep quality
- mobilization
- loss of functional ability
- length of stay
- sedation
- nocturnal nursing events
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 70 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Hvidovre University Hospital Other
Overall Clinical Trial Officials and Contacts
Nicolai B Foss, MD Study Director Hvidovre University Hospital
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00286936
Study ID Number: HHSG-RCT-05
ClinicalTrials.gov Identifier: NCT00286936
Health Authority: Denmark: The Ministry of the Interior and Health
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00286936
