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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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Propofol

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

Group Type EXPERIMENTAL

EEG monitoring

Intervention Type DEVICE

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

Target Controlled Infusion

Intervention Type DEVICE

Steady state effect site concentrations of remifentanil administrated to all patients.

Sevoflurane

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

Group Type EXPERIMENTAL

EEG monitoring

Intervention Type DEVICE

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

Target Controlled Infusion

Intervention Type DEVICE

Steady state effect site concentrations of remifentanil administrated to all patients.

Interventions

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EEG monitoring

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

Intervention Type DEVICE

Target Controlled Infusion

Steady state effect site concentrations of remifentanil administrated to all patients.

Intervention Type DEVICE

Other Intervention Names

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TCI

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes