Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Heart Rate Variability Under Propofol and Sevoflurane

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.
 
ClinicalTrials.gov Identifier: NCT03098875
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Pr Isabelle CONSTANT, Hôpital Armand Trousseau

Tracking Information
First Submitted Date  ICMJE January 9, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date April 4, 2017
Study Start Date  ICMJE January 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
  • Spectral analysis of heart rate variability with a bispectral index of 25 [ Time Frame: During surgical procedure ]
    Fast Fourier Transform applied to heart rate signal recording
  • Spectral analysis of heart rate variability with a bispectral index of 55 [ Time Frame: During surgical procedure ]
    Fast Fourier Transform applied to heart rate signal recording
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heart Rate Variability Under Propofol and Sevoflurane
Official Title  ICMJE Spectral Analysis of Heart Rate Variability at BIS 25 and BIS 55 Under Propofol or Sevoflurane
Brief Summary Patients were randomized into 2 groups according to the anesthetic, propofol or sevoflurane. Induction and maintenance were standardized, and after the end of surgery, two steady-state recordings were performed at BIS 25 and BIS 55. Bispectral Index and ECG were continuously recorded and cardiac autonomic nervous activity was investigated using spectral analysis of RR Interval variability
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE General Anesthesia
Intervention  ICMJE
  • Drug: Sevoflurane
    General anesthesia using sevoflurane as a hypnotic agent
  • Drug: Propofol
    General anesthesia using propofol as a hypnotic agent
  • Drug: Remifentanil
    General anesthesia using remifentanil as an analgesic.
Study Arms  ICMJE
  • Active Comparator: Sevoflurane

    General anesthesia using sevoflurane as a hypnotic agent, and remifentanil as an analgesic.

    Two steady state periods of 10 minutes each, one with a steady bispectral index at 25 +/- 5, the other with a steady bispectral index at 55 +/- 5. Continuous recording of heart rate during the last minute of each steady-state. Off-line spectral analysis of heart rate variability.

    Interventions:
    • Drug: Sevoflurane
    • Drug: Remifentanil
  • Active Comparator: Propofol

    General anesthesia using propofol as a hypnotic agent, and remifentanil as an analgesic.

    Two steady state periods of 10 minutes each, one with a steady bispectral index at 25 +/- 5, the other with a steady bispectral index at 55 +/- 5. Continuous recording of heart rate during the last minute of each steady-state. Off-line spectral analysis of heart rate variability.

    Interventions:
    • Drug: Propofol
    • Drug: Remifentanil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2017)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA risk classification 1 or 2,
  • scheduled for middle ear surgery, or cardiovascular ANS activity.

Exclusion Criteria:

  • preoperative medications that interfere with the autonomic nervous system
  • preoperative medications that interfere with the central nervous system
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03098875
Other Study ID Numbers  ICMJE HRV Propofol Sevoflurane
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pr Isabelle CONSTANT, Hôpital Armand Trousseau
Study Sponsor  ICMJE Hôpital Armand Trousseau
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hôpital Armand Trousseau
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP