CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
electroencephalography (EEG) +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03209323
NCT03209323N/ACompleted
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Influence of Volatile Induction of General Anaesthesia With Sevoflurane Using Two Different Techniques and Intravenous Induction Using Propofol on the Epileptiform Electroencephalograph Patterns:

Medical University of Silesia·interventional·Posted Jul 6, 2017·Updated Jul 11, 2017

In Brief

A clinical study evaluating electroencephalography (EEG), bispectral index (BIS), and 2 other interventions for General Anaesthesia and 4 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The aim of the study was to assess the influence of volatile induction of general anaesthesia with sevoflurane using two different techniques and intravenous anaesthesia with propofol on the possible presence of epileptiform electroencephalograph patterns during the induction of general anaesthesia. We aimed to verify whether presence of epileptiform patterns (EPs) defined as polispikes (PS), rhytmic polispikes (RPS), periodic epileptiform discharges (PED) on Electroencephalographs (EEGs) influence the behaviour of values of the Bispectral Index (BIS), State (SE) and Response (RE), A-line Auto Regressive Index (AAI) derived from middle latency auditory evoked potentials (MLAEP) during the induction of general anaesthesia using abovementioned techniques and such variations may be useful in detection of presence of EPs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneral Anaesthesia, Depth of Anaesthesia, Intraoperative Awareness, Seizures, Electroencephalography
CountriesPoland
CollaboratorsSilesian University of Medicine

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 6, 2017
Enrollment StartJan 1, 2007
Primary CompletionDec 13, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.0 years ago

Interventions

electroencephalography (EEG)device

Four EEG channels were recorded using electrode positions as defined in the International 10-20 System with Ag/AgCl2 cup electrodes (Spes Medica) attached to the scalp with EC2 Electrode Cream (Grass Technologies). The impedance was set below 1 k, and the electrodes were attached to module S/5 E-EEG of the anaesthetic monitor S/5 (GE Healthcare).

bispectral index (BIS)device

The BIS score was derived from a sensor (Aspect Medical Systems) positioned diagonally on the patients' foreheads according to producer's instructions.

response and state entropy (RE and SE)device

The respone and state entropy (RE and SE) score was derived from a sensor (Aspect Medical Systems) positioned diagonally on the patients' foreheads according to producer's instructions.

middle latency auditory evoked potentials (MLAEP)device

value of A-line Auto Regressive Index (AAI) derived from middle latency auditory evoked potentials (MLAEP) (A-line Monitor, Danmeter A/S, Odense, Denmark) was observed which measures the central nervous system responsiveness to a specific auditory stimulus