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

Electroencephalographic 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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Device: EEG monitoring; Device: Target Controlled Infusion

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Departement d'anesthesie Hopital Armand Trousseau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bispectral profiles	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.	The average value of BIS is calculated on the last minute of each ten minutes steady state period .

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hôpital Armand Trousseau
• Collaborators: Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: September 4, 2016
• First Posted (Estimate): September 9, 2016

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Children; Propofol; Sevoflurane; Bispectral Index; Electroencephalographic signs
• Other Study ID Numbers: BIS and EEG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No