SEP Changes During Deep Anesthesia
SEPinBSP
The Effect of Burst-suppression-pattern in EEG on Generating Somatosensory Evoked Potentials
1 other identifier
interventional
60
1 country
1
Brief Summary
The relation between burst and suppression periods in transcranial and direct cortical recorded EEG with cortical amplitudes median nerve somatosensory evoked potentials is studied. 60 patients are included in this study: 15 patients undergoing brain tumor surgery, 15 spine surgery (University Hospital Düsseldorf) and 30 patients during general surgical procedures (Helios Klinikum Wuppertal).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 16, 2015
CompletedFirst Posted
Study publicly available on registry
March 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMarch 20, 2015
March 1, 2015
1 year
March 16, 2015
March 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SEP ampiltude in burst-suppression-EEG
2 hours
Study Arms (3)
Brain surgery
EXPERIMENTALSomatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography
Spine surgery
EXPERIMENTALSomatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography
General surgery
ACTIVE COMPARATORSomatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- periodical consumption of drugs and pharmaceuticals which influence cortical excitability
- intraoperative contraindication for required depth of anaesthesia
- neurological pre-existing illness
- advanced hepatic insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neurosurgical Clinic
Düsseldorf, 40225, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Szelényi, Prof.
Neurosurgical Clinic, Heinrich Heine University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr. med. Andrea Szelényi
Study Record Dates
First Submitted
March 16, 2015
First Posted
March 20, 2015
Study Start
March 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2017
Last Updated
March 20, 2015
Record last verified: 2015-03