Heart Rate Variability During Sleep After Fast-track Surgery

This study has been completed.
Information provided by (Responsible Party):
Lene Krenk, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
First received: July 11, 2011
Last updated: December 13, 2011
Last verified: December 2011
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.

Heart Rate Variablity

Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • heart rate variability [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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)
patient characteristics are specified in H-2-2010-011
age matched to patients described in protocol H-2-2010-011


Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393236

Copenhagen, Denmark
Sponsors and Collaborators
Lene Krenk
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 
Study First Received: July 11, 2011
Last Updated: December 13, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

ClinicalTrials.gov processed this record on May 04, 2016