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

Phase 4

Terminated

• Conditions: Hip Fracture; Delirium

• Registration Number: NCT00286936
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2006-02-03
• Study First Submitted QC: 2006-02-03
• Study First Posted: 2006-02-06
• Status Verified: 2006-09
• Study Completion: 2007-01
• Last Update Submitted: 2011-08-29
• Last Update Posted: 2011-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence and severity of postoperative delirium

Secondary Outcome Measures

Name	Time	Method
mobilization
Sleep quality
nocturnal nursing events
loss of functional ability
length of stay
sedation

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark