EEG Profiles During General Anesthesia : a Comparative Study Between Sevoflurane and Propofol

Sponsor
Hôpital Armand Trousseau (Other)
Overall Status
Completed
CT.gov ID
NCT02893904
Collaborator
Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau (Other)
73
1
2
23
3.2

Study Details

Study Description

Brief Summary

A cerebral pharmacodynamic feedback may help the anesthesiologist to adjust anesthetics administration. The BIS, which provides a single number resulting from an algorithm calculated from cortical EEG parameters, may play this role.Moreover, halogenated agents and propofol may have different EEG effects, which might interfere on measured BIS values.

The aim of this prospective randomized study was to compare, in steady state conditions, the EEG profiles in children anesthetized with sevoflurane (S) or propofol (P) : for both anesthetics, the BIS-concentration relationship and raw EEG were analysed at different levels of general anesthesia.

Condition or Disease Intervention/Treatment Phase
  • Device: EEG monitoring
  • Device: Target Controlled Infusion
N/A

Detailed Description

Children will be prospectively included and randomly assigned in two groups : Propofol (P) Group or Sevoflurane (S) Group.

Steady state periods will be performed at a fixed randomized concentration between 2, 3, 4, 5 and 6 mcg/ml of stable Ct P concentration in the P group and between 1,2,3,4,5 % of FeS in the S group.

At the end of each steady-state period the BIS value was noted and the relationship between BIS and anesthetic concentrations will be studied using non linear regression. For all steady state periods, EEG traces will be reviewed to determine the presence of epileptiform signs (ES) and spectral EEG signal analysis with fast Fourier transformation (FFT) will be performed.

Study Design

Study Type:
Interventional
Actual Enrollment :
73 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Screening
Official Title:
Electroencephalographic Profiles During General Anesthesia : a Comparative Study Between Sevoflurane and Propofol.
Study Start Date :
Jan 1, 2005
Actual Primary Completion Date :
Dec 1, 2006
Actual Study Completion Date :
Dec 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Propofol

General anesthesia by TCI Propofol and Remifentanil guided by BIS EEG monitoring intervention

Device: EEG monitoring
Steady state concentrations periods of Propofol for EEG data analyzes. Remifentanil was administrated at constant rate in all patients.

Device: Target Controlled Infusion
Steady state effect site concentrations of remifentanil administrated to all patients.
Other Names:
  • TCI
  • Experimental: Sevoflurane

    General anesthesia by Sevoflurane and Remifentanil guided by BIS EEG monitoring intervention

    Device: EEG monitoring
    Steady state concentrations periods of Propofol for EEG data analyzes. Remifentanil was administrated at constant rate in all patients.

    Device: Target Controlled Infusion
    Steady state effect site concentrations of remifentanil administrated to all patients.
    Other Names:
  • TCI
  • Outcome Measures

    Primary Outcome Measures

    1. Bispectral profiles [The average value of BIS is calculated on the last minute of each ten minutes steady state period .]

      For each patient, before surgery and according to the constraints of operating schedule, one or two 10 min steady state periods were performed at a fixed FeS randomized between 1, 2, 3, 4 and 5 % of Sevoflurane in the Sevoflurane group or at a fixed Ct P randomized between 2, 3, 4, 5 and 6 mcg/ml in the propofol group.

    Secondary Outcome Measures

    1. Incidence of epileptiform EEG signs [Last minute of each ten minutes steady state period]

    2. Spectral analysis of EEG signal [Last minute of each ten minutes steady state period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • from five to eighteen year of age, ASA 1 or 2, scheduled for middle ear surgery
    Exclusion Criteria:
    • obesity (body mass index > percentile 97); history of cardiac, pulmonary, or renal disease; known neurological or neuromuscular disorders; preoperative administration of medications known to interfere with the central nervous system

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Departement d'anesthesie Hopital Armand Trousseau Paris France 75012

    Sponsors and Collaborators

    • Hôpital Armand Trousseau
    • Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pr Isabelle CONSTANT, Pr Isabelle CONSTANT, Hôpital Armand Trousseau
    ClinicalTrials.gov Identifier:
    NCT02893904
    Other Study ID Numbers:
    • BIS and EEG
    First Posted:
    Sep 9, 2016
    Last Update Posted:
    Jul 9, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Pr Isabelle CONSTANT, Pr Isabelle CONSTANT, Hôpital Armand Trousseau

    Study Results

    No Results Posted as of Jul 9, 2020