Somatosensory Evoked Potentials, and ElectroencephalographySEPinBSPNCT02394002
SEP Changes During Deep Anesthesia
A study testing Propofol in people with Somatosensory Evoked Potentials, and Electroencephalography, run by Andrea Szelenyi at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Somatosensory Evoked Potentials, and Electroencephalography
- What is being tested?
- Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- periodical consumption of drugs and pharmaceuticals which influence cortical excitability
- intraoperative contraindication for required depth of anaesthesia
- neurological pre-existing illness
- advanced hepatic insufficiency
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Neurosurgical Clinic
Düsseldorf, 40225
Andrea Szelényi, Prof., +49 211 8117646, andrea.szelenyi@uni-duesseldorf.de
Sebastian Braun, Dr., +49 211 8107425, sebastian.braun@med.uni-duesseldorf.de
About this study
Official title: The Effect of Burst-suppression-pattern in EEG on Generating Somatosensory Evoked Potentials
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).
- Being tested
- Propofol
- Keywords
- EEG, burst-suppression, N20, SEP, median nerve, facilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
| Study group | Role | What they receive |
|---|---|---|
| Brain surgery | Experimental | Somatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography Receives: Drug: Propofol |
| Spine surgery | Experimental | Somatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography Receives: Drug: Propofol |
| General surgery | Active comparator | Somatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
SEP ampiltude in burst-suppression-EEG
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatosensory Evoked Potentials, and ElectroencephalographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrea Szelenyi
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Anaesthesiology, Heinrich Heine University, Department of Anesthesiology, Helios Klinikukm Wuppertal
- Responsible party
- Sponsor-investigator, Andrea Szelenyi, Heinrich-Heine University, Duesseldorf
- Investigators
- Andrea Szelényi, Prof., Principal investigator, Neurosurgical Clinic, Heinrich Heine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394002
- Sponsor's protocol ID
- 2013071151
- Acronym
- SEPinBSP
- Status last verified
- Mar 2015
- First submitted
- 16 Mar 2015
- Last updated
- 20 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Burst-suppression-pattern in EEG on Generating Somatosensory Evoked Potentials
- ClinicalTrials.gov ID
- NCT02394002
- Acronym / sponsor ID
- SEPinBSP / 2013071151
- Keywords
- EEG, burst-suppression, N20, SEP, median nerve, facilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Andrea SzelenyiUniversity, hospital or other
- Collaborators
- Department of Anaesthesiology, Heinrich Heine University, Department of Anesthesiology, Helios Klinikukm Wuppertal
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brain surgery | Experimental | Drug: PropofolSomatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography |
| Spine surgery | Experimental | Drug: PropofolSomatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography |
| General surgery | Active comparator | Drug: PropofolSomatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- periodical consumption of drugs and pharmaceuticals which influence cortical excitability
- intraoperative contraindication for required depth of anaesthesia
- neurological pre-existing illness
- advanced hepatic insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol | Drug | Brain surgery, General surgery, Spine surgery |
Primary outcome
SEP ampiltude in burst-suppression-EEG
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Szelényi, Prof. principal investigator
Neurosurgical Clinic, Heinrich Heine University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol in people with Somatosensory Evoked Potentials, and Electroencephalography, run by Andrea Szelenyi at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Szelényi, Prof. (+49 211 8117646, andrea.szelenyi@uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SEP ampiltude in burst-suppression-EEG (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015; AzTrials last refreshed its copy on 26 Oct 2026.