NCT02893904

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Hôpital Armand Trousseau · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2005-01-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2016-09-09
• Last updated: 2020-07-09

Locations

1 site across 1 country: France