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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: ClinicalTrials.gov
Last refreshed on: 30 March 2015
Main ID:  NCT02394002
Date of registration: 16/03/2015
Prospective Registration: No
Primary sponsor: Andrea Szelenyi
Public title: SEP Changes During Deep Anesthesia SEPinBSP
Scientific title: The Effect of Burst-suppression-pattern in EEG on Generating Somatosensory Evoked Potentials
Date of first enrolment: March 2015
Target sample size: 60
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT02394002
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science  
Phase:  N/A
Countries of recruitment
Germany
Contacts
Name:     Andrea Szelényi, Prof.
Address: 
Telephone: +49 211 8117646
Email: andrea.szelenyi@uni-duesseldorf.de
Affiliation: 
Name:     Andrea Szelényi, Prof.
Address: 
Telephone:
Email:
Affiliation:  Neurosurgical Clinic, Heinrich Heine University
Name:     Andrea Szelényi, Prof.
Address: 
Telephone: +49 211 8117646
Email: andrea.szelenyi@uni-duesseldorf.de
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- Location Helios Klinikum Wuppertal: neurological healthy patients, which undergo an
elective surgery under general anaesthesia

- Location Department of Neurosurgery, University Hospital Düsseldorf: all patients
with intracranial interventions and the possibility to place a stripe electrode
without complications on cortex (it is decided by the surgeon while surgery because
of the situs and tumorlocation)

Exclusion Criteria:

- periodical consumption of drugs and pharmaceuticals which influence cortical
excitability

- intraoperative contraindication for required depth of anaesthesia

- neurological pre-existing illness

- advanced hepatic insufficiency



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Somatosensory Evoked Potentials, and Electroencephalography
Intervention(s)
Drug: Propofol
Primary Outcome(s)
SEP ampiltude in burst-suppression-EEG [Time Frame: 2 hours]
Secondary Outcome(s)
Secondary ID(s)
2013071151
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Department of Anaesthesiology, Heinrich Heine University
Department of Anesthesiology, Helios Klinikukm Wuppertal
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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