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

NCT ID: NCT00286936

Last Updated: 2011-08-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2007-01-31

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.

Conditions

Hip Fracture; Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Zolpidem

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IMK Fonden

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Nicolai B Foss, MD

Role: STUDY_DIRECTOR

Hvidovre University Hospital

Locations

Hvidovre University Hospital

Hvidovre, , Denmark

Countries

Denmark

Other Identifiers

HHSG-RCT-05

Identifier Type: -

Identifier Source: org_study_id