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Heart Rate Variability During Sleep After Fast-track Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lene Krenk, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01393236
First received: July 11, 2011
Last updated: December 13, 2011
Last verified: December 2011
History of Changes
  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 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)
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

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.

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

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

No publications provided

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 19, 2013