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

Phase 4TerminatedNCT00286936

Hvidovre University Hospital96 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Hip Fracture Delirium

Interventions

ZolpidemDRUG

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Hvidovre University Hospital

Hvidovre, Denmark

Outcomes

Primary Outcomes

Incidence and severity of postoperative delirium

Secondary Outcomes

Sleep quality

mobilization

loss of functional ability

length of stay

sedation

nocturnal nursing events

Data from ClinicalTrials.gov

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