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Heart Rate Variability Under Propofol and Sevoflurane

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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

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

Condition or disease Intervention/treatment Phase
General Anesthesia Drug: Sevoflurane Drug: Propofol Drug: Remifentanil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Spectral Analysis of Heart Rate Variability at BIS 25 and BIS 55 Under Propofol or Sevoflurane
Study Start Date : January 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Drug: Sevoflurane
General anesthesia using sevoflurane as a hypnotic agent

Drug: Remifentanil
General anesthesia using remifentanil as an analgesic.

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.

Drug: Propofol
General anesthesia using propofol as a hypnotic agent

Drug: Remifentanil
General anesthesia using remifentanil as an analgesic.




Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   13 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03098875


Locations
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France
Departement d'anesthesie Hopital Armand Trousseau
Paris, France, 75012
Sponsors and Collaborators
Hôpital Armand Trousseau
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Responsible Party: Pr Isabelle CONSTANT, Professor, Hôpital Armand Trousseau
ClinicalTrials.gov Identifier: NCT03098875    
Other Study ID Numbers: HRV Propofol Sevoflurane
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Remifentanil
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation