General AnesthesiaNCT02995447
Differential Effects of Propofol on Scalp and Intracranial EEG
An observational study of General Anesthesia, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
The anesthetic propofol has a dose-depending effect on the EEG, which differs in comparison between scalp and intracerebral electrodes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Anesthesia
- What is being tested?
- differences between surface and intracerebral EEG
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2012to Dec 2018
- Phase
- Observational
- 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
Study population: Patients suffering from epilepsy
Who may be able to join
- Patients with implanted intracerebral EEG electrodes
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
Bonn, 53105
Martin Soehle, MD, PhD, martin.soehle@ukb.uni-bonn.de
Florian Mormann, MD, PhD, Florian.Mormann@ukb.uni-bonn.de
About this study
Official title: Differential Effects of Propofol on Scalp and Intracranial Electroencephalogram
The anesthetic propofol has a dose-depending effect on the EEG, which differs in comparison between scalp and intracerebral electrodes
Read the detailed description
The electrical activity of the brain (electroencephalogram EEG) is usually assessed from the surface of the head, which is approximately 1-2 cm above the cerebral cortex. Thus, the spatial resolution of the EEG is low, and the electrical activity recorded originates from a multitude of neurons.
Deep brain structures such as the hippocampus also generate electrical activity which cannot be assessed from the surface of the head. However, in some patients electrodes are implanted into the brain to look for the origin of epileptic seizures. Along the way, these intracerebral electrodes enable to record the EEG from intracerebral structures which are generated from few neurons only. Once the origin of epilepsy has been identified, the intracerebral electrodes are removed under general anesthesia.
Anesthetics such as propofol characteristically modify the EEG in a dose-dependant manner. More over, the propofol effect on the EEG recorded from the surface is likely to be different from the intracerebral EEG, however little is known so far. Therefore we aim to investigate the differential effect of propofol on the superficial versus intracerebral recorded EEG.
- Conditions
- General Anesthesia
- Being tested
- differences between surface and intracerebral EEG
- Keywords
- propofol, electroencephalogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
differences between surface and intracerebral EEGOther
No intervention is performed. Im- and explantation of intracerebral electrodes is performed for clinical and not for study purposes. The only difference between study and non-study patients is that the surface as well as the intracerebral EEG is recorded and stored in the former, while it is discarded in the latter.
| Study group | Role | What they receive |
|---|---|---|
| epilepsy patients | The group consists of patients with therapy refractory epilepsy, in which intracerebral electrodes were implanted to locate the seizure origin and to determine whether the patients are eligible for epilepsy surgery. In an observational study, differences between surface and intracerebral EEG are recorded. Receives: Other: differences between surface and intracerebral EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG amplitude
EEG amplitude in comparison between scalp and intracranial recordings
Measured: up to two hours of EEG recording
EEG frequency spectrum
EEG frequency spectrum in comparison between scalp and intracranial recordings
Measured: up to two hours of EEG recording
Secondary outcomes (1)
EEG Burst Suppression Ratio
EEG Burst Suppression Ratio in comparison between scalp and intracranial recordings
Measured: up to two hours of EEG recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startNov 2012
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Soehle, University Hospital, Bonn
- Investigators
- Martin Soehle, MD, PhD, Principal investigator, Dept. of Anesthesiology and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995447
- Sponsor's protocol ID
- EPI_12
- Status last verified
- Dec 2017
- First submitted
- 3 Oct 2014
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of Propofol on Scalp and Intracranial Electroencephalogram
- ClinicalTrials.gov ID
- NCT02995447
- Acronym / sponsor ID
- EPI_12
- Conditions
- General Anesthesia
- Keywords
- propofol, electroencephalogram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Dec 2016 (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 anesthetic propofol has a dose-depending effect on the EEG, which differs in comparison between scalp and intracerebral electrodes
Detailed description
The electrical activity of the brain (electroencephalogram EEG) is usually assessed from the surface of the head, which is approximately 1-2 cm above the cerebral cortex. Thus, the spatial resolution of the EEG is low, and the electrical activity recorded originates from a multitude of neurons.
Deep brain structures such as the hippocampus also generate electrical activity which cannot be assessed from the surface of the head. However, in some patients electrodes are implanted into the brain to look for the origin of epileptic seizures. Along the way, these intracerebral electrodes enable to record the EEG from intracerebral structures which are generated from few neurons only. Once the origin of epilepsy has been identified, the intracerebral electrodes are removed under general anesthesia.
Anesthetics such as propofol characteristically modify the EEG in a dose-dependant manner. More over, the propofol effect on the EEG recorded from the surface is likely to be different from the intracerebral EEG, however little is known so far. Therefore we aim to investigate the differential effect of propofol on the superficial versus intracerebral recorded EEG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| epilepsy patients | – | Other: differences between surface and intracerebral EEGThe group consists of patients with therapy refractory epilepsy, in which intracerebral electrodes were implanted to locate the seizure origin and to determine whether the patients are eligible for epilepsy surgery. In an observational study, differences between surface and intracerebral EEG are recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from epilepsy
Key inclusion criteria (1 listed)
- Patients with implanted intracerebral EEG electrodes
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| differences between surface and intracerebral EEGNo intervention is performed. Im- and explantation of intracerebral electrodes is performed for clinical and not for study purposes. The only difference between study and non-study patients is that the surface as well as the intracerebral EEG is recorded and stored in the former, while it is discarded in the latter. | Other | epilepsy patients |
Primary outcome
EEG amplitude
Time frame: up to two hours of EEG recording
EEG amplitude in comparison between scalp and intracranial recordings
EEG frequency spectrum
Time frame: up to two hours of EEG recording
EEG frequency spectrum in comparison between scalp and intracranial recordings
1 secondary outcome
EEG Burst Suppression Ratio
Time frame: up to two hours of EEG recording
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Martin Soehle, MD, PhD principal investigator
Dept. of Anesthesiology and Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia, run by University Hospital, Bonn 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 1 inclusion and 1 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 5 Dec 2017. 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 Martin Soehle, MD, PhD (++49-228-287- ext. 11378, martin.soehle@ukb.uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG amplitude (time frame: up to two hours of EEG recording). The study lists 2 primary outcomes in all. 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 5 Dec 2017.