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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00286936
Other study ID # HHSG-RCT-05
Secondary ID
Status Terminated
Phase Phase 4
First received February 3, 2006
Last updated August 29, 2011
Start date February 2004
Est. completion date January 2007

Study information

Verified date September 2006
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 96
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 70 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Zolpidem


Locations

Country Name City State
Denmark Hvidovre University Hospital Hvidovre

Sponsors (2)

Lead Sponsor Collaborator
Hvidovre University Hospital IMK Fonden

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and severity of postoperative delirium
Secondary Sleep quality
Secondary mobilization
Secondary loss of functional ability
Secondary length of stay
Secondary sedation
Secondary nocturnal nursing events
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