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Heart Rate Variability During Sleep After Fast-track Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01393236
First Posted: July 13, 2011
Last Update Posted: December 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lene Krenk, Rigshospitalet, Denmark
  Purpose
Based on prior findings concerning sleep disturbances, in particular REM sleep disturbances, after fast-track hip and knee arthroplasty (H-2-2010-011) we performed a supplemental analysis of heart rate variablity after arousals during sleep. We compared preoperative and postoperative results.

Condition
Heart Rate Variablity

Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by Lene Krenk, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • heart rate variability [ Time Frame: 24 hours ]
    heart rate variability measured 5 beats before arousel and 15 beats after arousel in different sleep stages.


Enrollment: 10
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients
patient characteristics are specified in H-2-2010-011
controls
age matched to patients described in protocol H-2-2010-011

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
We selected patients undergoing fasttrack hip and knee arthoplasty in fast-track setip. The underwent sleep monotoring for 1 preoperative night and continously during hospitalisation, and for 1 night at home after surgery.
Criteria

Inclusion criteria (for the control group):

  • Age > 60 years

Exclusion criteria:

  • surgery within the last 2 months
  • known sleep disorder (eg. sleep apnea)
  • daily beta blocker treatment
  • daily dopamine treatment

This protocol only concentrates on the healthy controls for the patient described in H-2-2010-011.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393236


Locations
Denmark
Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Lene Krenk
Investigators
Principal Investigator: Lene Krenk, MD Rigshospitalet, Denmark
  More Information

Responsible Party: Lene Krenk, Doctor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01393236     History of Changes
Other Study ID Numbers: H-2-2010-011a
First Submitted: July 11, 2011
First Posted: July 13, 2011
Last Update Posted: December 14, 2011
Last Verified: December 2011