Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT03209323 |
Date of registration:
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02/07/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Epileptiform EEG Patterns During Induction of General Anaesthesia With Sevoflurane Compared to Those With Propofol
EEG |
Scientific title:
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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: |
Date of first enrolment:
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January 1, 2007 |
Target sample size:
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60 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03209323 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Poland
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Contacts
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Name:
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Przemyslaw Jalowiecki |
Address:
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Telephone:
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Email:
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Affiliation:
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Silesian University of Medicine |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Electroencephalography
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Depth of Anaesthesia
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General Anaesthesia
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Intraoperative Awareness
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Seizures
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Intervention(s)
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Device: bispectral index (BIS)
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Device: response and state entropy (RE and SE)
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Device: middle latency auditory evoked potentials (MLAEP)
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Device: electroencephalography (EEG)
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Primary Outcome(s)
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presence of epileptiform patterns in patients EEGs
[Time Frame: intraoperative]
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Secondary Outcome(s)
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observance of BIS score behaviour during presence of epileptiform patterns in patients EEGs
[Time Frame: intraoperative]
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observance of values of middle latency auditory evoked potentials behaviour during presence of epileptiform patterns in patients
[Time Frame: intraoperative]
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observance of values of state and response entropy behaviour during presence of epileptiform patterns in patients
[Time Frame: intraoperative]
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Secondary ID(s)
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SilesianMUKOAIIT6
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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