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

NCT02893904 | Completed

• 1 other identifier: BIS and EEG
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

Propofol; Sevoflurane; Bispectral Index; Children; Electroencephalographic signs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Propofol

EXPERIMENTAL

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

Device: EEG monitoring; Device: Target Controlled Infusion

Sevoflurane

EXPERIMENTAL

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

Device: EEG monitoring; Device: Target Controlled Infusion

Interventions

EEG monitoring DEVICE

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

Propofol; Sevoflurane

Target Controlled Infusion DEVICE

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

Also known as: TCI

Propofol; Sevoflurane

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• from five to eighteen year of age, ASA 1 or 2, scheduled for middle ear surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Armand Trousseau: lead
• Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau: collaborator

Study Sites (1)

Departement d'anesthesie Hopital Armand Trousseau

Paris, 75012, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pr Isabelle CONSTANT

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: September 9, 2016
• Study Start: January 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)