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Heart Rate Variability Under Propofol and Sevoflurane

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03098875
Enrollment
40
Registered
2017-04-04
Start date
2009-01-31
Completion date
2010-09-30
Last updated
2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

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

Interventions

DRUGSevoflurane

General anesthesia using sevoflurane as a hypnotic agent

DRUGPropofol

General anesthesia using propofol as a hypnotic agent

DRUGRemifentanil

General anesthesia using remifentanil as an analgesic.

Sponsors

Hôpital Armand Trousseau
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
13 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Spectral analysis of heart rate variability with a bispectral index of 25During surgical procedureFast Fourier Transform applied to heart rate signal recording
Spectral analysis of heart rate variability with a bispectral index of 55During surgical procedureFast Fourier Transform applied to heart rate signal recording

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026