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

August 7, 2012 updated by: Lene Krenk, Rigshospitalet, Denmark
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Gentofte, Denmark
        • Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Pacebo tablet, blinded given on the first night after surgery
EXPERIMENTAL: Zolpidem
Drug: Zolpidem
The effect of Zolpidem 10 mg for the first night after surgery is asssessed using PSG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sleep time on the first postoperative night compared to preoperatively.
Time Frame: first night postoperatively - 24 hours
The primary endpoint is an evaluation of sleep stages on the first night postoperatively compared to preoperative measures for the same individual
first night postoperatively - 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ANTICIPATED)

August 1, 2012

Study Completion (ANTICIPATED)

October 1, 2012

Study Registration Dates

First Submitted

February 6, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (ESTIMATE)

March 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 8, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2011-022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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