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NCT03098875 Clinical Trial

Heart Rate Variability Under Propofol and Sevoflurane

General Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03098875
Other study ID # HRV Propofol Sevoflurane
Secondary ID
Status Completed
Phase N/A
First received January 9, 2017
Last updated March 28, 2017
Start date January 2009
Est. completion date September 2010

Study information
Verified date March 2017
Source Hôpital Armand Trousseau
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date September 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 13 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sevoflurane
General anesthesia using sevoflurane as a hypnotic agent
• Propofol
General anesthesia using propofol as a hypnotic agent
• Remifentanil
General anesthesia using remifentanil as an analgesic.

Locations
Country Name City State
France Departement d'anesthesie Hopital Armand Trousseau Paris

Sponsors (1)
Lead Sponsor Collaborator
Hôpital Armand Trousseau

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Spectral analysis of heart rate variability with a bispectral index of 25 Fast Fourier Transform applied to heart rate signal recording During surgical procedure
Primary Spectral analysis of heart rate variability with a bispectral index of 55 Fast Fourier Transform applied to heart rate signal recording During surgical procedure
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