Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement

Rigshospitalet, Denmark20 enrolled

Overview

Sleep after surgery has been found to be very distrubed immediately after major surgery. This is also seen after fast-track hip and knee replacement with length of stay of less than 3 days. Disturbed sleep has many adverse effects i.e. fatigue, possible hyperalgesia and decline in cognitive abilities.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Sleep Duration on the First Night After Surgery

Interventions

ZolpidemDRUG

The effect of Zolpidem 10 mg for the first night after surgery is asssessed using PSG

PlaceboDRUG

Pacebo tablet, blinded given on the first night after surgery

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Total hip or knee replacement in fast-track setup * Age 60 years or above * ASA class 1-3 Exclusion Criteria: * Anesthesia within the pas 30 days * Daily use of alcohol \> 21 units / week * Use of anxiolytics or hypnotics within the past 30 days * Inability to read and understand Danish * Marked reduction of sight or hearing * Parkinson's disease or other neurological disaese causing function deficits * Inability to cooperate to sleep monitoring * allergy to the drug tested

Locations (1)

Gentofte Hospital

Gentofte Municipality, Denmark

Outcomes

Primary Outcomes

Change in sleep time on the first postoperative night compared to preoperatively.

The primary endpoint is an evaluation of sleep stages on the first night postoperatively compared to preoperative measures for the same individual

Time frame: first night postoperatively - 24 hours

Data from ClinicalTrials.gov

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