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

Condition(s) targeted: Hip Fracture; Delirium

Intervention: Zolpidem (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hvidovre University Hospital

Official(s) and/or principal investigator(s):
Nicolai B Foss, MD, Study Director, Affiliation: Hvidovre University Hospital

Overall contact:
Nicolai B Foss, MD, Phone: 0045 36323125, Email: nicolai.bang.foss@hh.hosp.dk

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

Official title: Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics Vs Placebo

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Incidence and severity of postoperative delirium

Secondary outcome:

Sleep quality

mobilization

loss of functional ability

length of stay

sedation

nocturnal nursing events

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.

Minimum age: 70 Years. Maximum age: N/A. Gender(s): Both.

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

Nicolai B Foss, MD, Phone: 0045 36323125, Email: nicolai.bang.foss@hh.hosp.dk

Hvidovre University Hospital, Hvidovre 2650, Denmark; Recruiting
Nicolai B Foss, MD, Phone: 0045 36323125, Email: nicolai.bang.foss@hh.hosp.dk

Starting date: February 2004
Ending date: December 2006
Last updated: September 13, 2006