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CompletedNCT03098875Updated Apr 4, 2017

Heart Rate Variability Under Propofol and Sevoflurane

An interventional study of Sevoflurane and Propofol in General Anesthesia, sponsored by Hôpital Armand Trousseau. Completed at 1 site in France. Open to participants aged 13 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-04-04.

Sponsored by Hôpital Armand Trousseau · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
13 Years to 40 Years
Sex
All
01

Study 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

02

Conditions studied

  • General Anesthesia
03

In context

Lead sponsor

Hôpital Armand Trousseau is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • preoperative medications that interfere with the autonomic nervous system
  • preoperative medications that interfere with the central nervous system
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • 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 · 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.

    Drug: Propofol · Drug: Remifentanil

Interventions

  • General anesthesia using sevoflurane as a hypnotic agent

  • General anesthesia using propofol as a hypnotic agent

  • General anesthesia using remifentanil as an analgesic.

06

What researchers measure

Primary outcomes

  1. Spectral analysis of heart rate variability with a bispectral index of 25

    Fast Fourier Transform applied to heart rate signal recording

    Time frame: During surgical procedure

  2. Spectral analysis of heart rate variability with a bispectral index of 55

    Fast Fourier Transform applied to heart rate signal recording

    Time frame: During surgical procedure

07

Study locations

1 site
  • Departement d'anesthesie Hopital Armand Trousseau
    Paris, 75012, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2009, a primary completion of Dec 2009 and a completion of Sep 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2017
First posted
Apr 4, 2017
Start
Jan 2009
Primary completionActual
Dec 2009
CompletionActual
Sep 2010
Last update
Apr 4, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03098875
Lead sponsor
Hôpital Armand Trousseau
Responsible party
Pr Isabelle CONSTANT (Professor, Hôpital Armand Trousseau) — Principal investigator
First posted
Apr 4, 2017
Start date
Jan 2009
Primary completion
Dec 2009
Completion
Sep 2010
Last update
Apr 4, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Sevoflurane · Propofol

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