World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03209323
Date of registration: 02/07/2017
Prospective Registration: No
Primary sponsor: Medical University of Silesia
Public title: Epileptiform EEG Patterns During Induction of General Anaesthesia With Sevoflurane Compared to Those With Propofol EEG
Scientific title: Influence of Volatile Induction of General Anaesthesia With Sevoflurane Using Two Different Techniques and Intravenous Induction Using Propofol on the Epileptiform Electroencephalograph Patterns:
Date of first enrolment: January 1, 2007
Target sample size: 60
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03209323
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Single (Participant).  
Phase:  N/A
Countries of recruitment
Poland
Contacts
Name:     Przemyslaw Jalowiecki
Address: 
Telephone:
Email:
Affiliation:  Silesian University of Medicine
Key inclusion & exclusion criteria

Inclusion Criteria:

- an American Society of Anaesthesiologists (ASA) score I-II

- written informed consent to undergo general anaesthesia

Exclusion Criteria:

- history of epilepsy, medical treatment that might interfere with the EEG (e.g.,
tranquilizers, antiepileptic drugs), pregnancy, drug or alcohol abuse, history of
neurological disease or a neurosurgical operation that would impair EEG or BIS monitoring,
history of pulmonary disease, or the presence of signs predicting difficult mask
ventilation or intubation. any pre-existing epileptic EEG patterns in standard 30-minute
initial EEG recordings performed in all the patients participating in the study.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Electroencephalography
Depth of Anaesthesia
General Anaesthesia
Intraoperative Awareness
Seizures
Intervention(s)
Device: bispectral index (BIS)
Device: response and state entropy (RE and SE)
Device: middle latency auditory evoked potentials (MLAEP)
Device: electroencephalography (EEG)
Primary Outcome(s)
presence of epileptiform patterns in patients EEGs [Time Frame: intraoperative]
Secondary Outcome(s)
observance of BIS score behaviour during presence of epileptiform patterns in patients EEGs [Time Frame: intraoperative]
observance of values of middle latency auditory evoked potentials behaviour during presence of epileptiform patterns in patients [Time Frame: intraoperative]
observance of values of state and response entropy behaviour during presence of epileptiform patterns in patients [Time Frame: intraoperative]
Secondary ID(s)
SilesianMUKOAIIT6
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Silesian University of Medicine
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history