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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00286936

Enrollment

Registered

2006-02-06

Start date

2004-02-29

Completion date

2007-01-31

Last updated

2011-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Hip Fracture

Keywords

Hip fracture, delirium, sleep disturbance, hypnotic

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.

Interventions

DRUGZolpidem

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence and severity of postoperative delirium	—

Secondary

Measure	Time frame
mobilization	—
loss of functional ability	—
Sleep quality	—
sedation	—
nocturnal nursing events	—
length of stay	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026