Anesthesia
Conditions
Keywords
Propofol, Sevoflurane, Bispectral Index, Children, Electroencephalographic signs
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.
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.
Interventions
DEVICEEEG monitoring
Steady state concentrations periods of Propofol for EEG data analyzes. Remifentanil was administrated at constant rate in all patients.
Steady state effect site concentrations of remifentanil administrated to all patients.
Sponsors
Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
Hôpital Armand Trousseau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Incidence of epileptiform EEG signs | Last minute of each ten minutes steady state period |
| Spectral analysis of EEG signal | Last minute of each ten minutes steady state period |
Countries
France
Outcome results
None listed