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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00286936
• Other study ID #: HHSG-RCT-05
• 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
• 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

• Delirium
• Fractures, Bone
• Hip Fracture
• Hip Fractures

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