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

NCT ID: NCT01551485

Last Updated: 2012-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Duration on the First Night After Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Zolpidem

Group Type EXPERIMENTAL

Zolpidem

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Pacebo tablet, blinded given on the first night after surgery

Interventions

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Zolpidem

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

Intervention Type DRUG

Placebo

Pacebo tablet, blinded given on the first night after surgery

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Lene Krenk

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lene Krenk, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Gentofte Hospital

Gentofte Municipality, , Denmark

Site Status

Countries

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Denmark

References

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Krenk L, Jennum P, Kehlet H. Postoperative sleep disturbances after zolpidem treatment in fast-track hip and knee replacement. J Clin Sleep Med. 2014 Mar 15;10(3):321-6. doi: 10.5664/jcsm.3540.

Reference Type DERIVED
PMID: 24634631 (View on PubMed)

Other Identifiers

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H-3-2011-022

Identifier Type: -

Identifier Source: org_study_id