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OpenTrials
Completed

NCT Number: NCT03098875

Heart Rate Variability Under Propofol and Sevoflurane

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

Completed

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Key information

Conditions

General Anesthesia

Age range

13 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departement d'anesthesie Hopital Armand Trousseau

Paris, 75012, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

General anesthesia using sevoflurane as a hypnotic agent

Propofol

Drug

General anesthesia using propofol as a hypnotic agent

Remifentanil

Drug

General anesthesia using remifentanil as an analgesic.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hôpital Armand Trousseau

Other

Registry information

Official study title

Spectral Analysis of Heart Rate Variability at BIS 25 and BIS 55 Under Propofol or Sevoflurane

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Apr 4, 2017
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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