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Completed

NCT Number: NCT02893904

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

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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Key information

Conditions

Anesthesia

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departement d'anesthesie Hopital Armand Trousseau

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EEG monitoring

Device

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

Target Controlled Infusion

Device

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

Other names: TCI

Primary outcomes

  1. Bispectral profiles

    Time frame: 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 outcomes

  1. Incidence of epileptiform EEG signs

    Time frame: Last minute of each ten minutes steady state period

  2. Spectral analysis of EEG signal

    Time frame: Last minute of each ten minutes steady state period

Sponsors and collaborators

Lead sponsor

Hôpital Armand Trousseau

Other

Collaborators

  • Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 9, 2016
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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