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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02893904
• Other study ID #: BIS and EEG
• Status: Completed
• Phase: N/A
• Start date: January 2005
• Est. completion date: December 2006

Study information

• Verified date: July 2020
• Source: Hôpital Armand Trousseau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• EEG monitoring
Steady state concentrations periods of Propofol for EEG data analyzes. Remifentanil was administrated at constant rate in all patients.
• Target Controlled Infusion
Steady state effect site concentrations of remifentanil administrated to all patients.

Locations

Country	Name	City	State
France	Departement d'anesthesie Hopital Armand Trousseau	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Hôpital Armand Trousseau	Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of epileptiform EEG signs		Last minute of each ten minutes steady state period
Secondary	Spectral analysis of EEG signal		Last minute of each ten minutes steady state period