Heart Rate Variability During Sleep After Fast-track Surgery

Heart Rate Variablity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01393236
• Other study ID #: H-2-2010-011a
• Status: Completed
• Phase: N/A
• First received: July 11, 2011
• Last updated: December 13, 2011
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Rate Variablity

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Lene Krenk

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate variability	heart rate variability measured 5 beats before arousel and 15 beats after arousel in different sleep stages.	24 hours	No