Heart Rate Variability During Sleep After Fast-track Surgery

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. Identifier: NCT01393236
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : December 14, 2011
Information provided by (Responsible Party):
Lene Krenk, Rigshospitalet, Denmark

Brief Summary:
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 or disease
Heart Rate Variablity

Study Type : Observational
Actual Enrollment : 10 participants
Time Perspective: Prospective
Study Start Date : July 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

patient characteristics are specified in H-2-2010-011
age matched to patients described in protocol H-2-2010-011

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

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
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.

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.

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 identifier (NCT number): NCT01393236

Copenhagen, Denmark
Sponsors and Collaborators
Lene Krenk
Principal Investigator: Lene Krenk, MD Rigshospitalet, Denmark

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