ElectroencephalographyPhase 1MOTANANCT03362775
EEG Analysis During Light Propofol Sedation
A Phase 1 study testing Propofol in people with Electroencephalography, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The hypothesis of this study is that propofol sedation does not affect the detectability of a movement intention in the EEG motor cortex signal. EEG signals will be recorded during the realization of intentional movements and movement intentions by the healthy volunteers, as well as during median nerve stimulation… Read more about this study
- Who is it for?
- Ages 18 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Electroencephalography
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2018to 31 Dec 2023
- Phase
- Phase 1
- 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 to 28 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Male
- affiliated to French social security
- normal physical examination
- 22 < body mass index < 28
Who cannot join
- Female
- allergy to propofol or one of the emulsion compounds (soja, egg)
- any pathology which may influence EEG recording or nerve conduction, such as diabetes, neuropathy, epilepsy, depression, psychotropic drug usage, drug usage)
- any allergic reaction associated with anesthesia
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Critical Care Medicine - University Hospital of Nancy
Nancy, 54500
Philippe Guerci, MD
About this study
The hypothesis of this study is that propofol sedation does not affect the detectability of a movement intention in the EEG motor cortex signal. EEG signals will be recorded during the realization of intentional movements and movement intentions by the healthy volunteers, as well as during median nerve stimulation before and during propofol perfusion according to a target control infusion. (0 µg/mL; 0.5 µg/mL and 1 µg/mL).
Read the detailed description
During an anesthesia, 0.1 to 0.2% of patients have an unexpected per-operative awakening, with the risk to have serious psychological consequences.
During a per-operative awakening, one of the first reflex of the patient is to move, but this is often not possible due to the use of neuromuscular blocking agents during the surgical procedure.
It is possible to detect a movement intention by analyzing the motor cortex EEG signal in awake volunteers. The same signal is present during light, non-painful median nerve stimulation.
The aim of this study is to determine wether this EEG signal can still be detected during light sedation by propofol, a drug commonly used during anesthesia. The investigators will include healthy male volunteers, who will make real movements, imagine a movement and have median nerve stimulations before and during a propofol infusion. The propofol will be infused according to a target controlled infusion with a effect-site concentration of 0.5 µg/mL and 1.0 µg/mL. Primary outcome is the detectability of event related desynchronization and event related synchronization in the EEG signal in the presence of propofol compared to the recordings without propofol
- Conditions
- Electroencephalography
- Being tested
- Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Target-controlled infusion of propofol with an effect-site concentration of 0.0 µL/mL; 0.5 µL/mL and 1.0 µL/mL.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Other | EEG will be recorded in all subjects before (0.0 µL/mL) and during a target controlled infusion of propofol (0.5 µL/mL and 1.0 µL/mL). Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
ERD/ERS amplitude
Amplitude of event-related synchronization (ERS) and event-related desynchronization (ERD) will be recorded within 2 seconds of each motor task (real movement, imaginary movement) as well as median nerve stimulation. This amplitude will be compared tio the value recorded in the absence of propofol.
Measured: 2 hours, during the experimentation
Secondary outcomes (2)
Dose relationship between ERD/ERS and propofol concentration
Investigators will analyze wether there is a relationship between the propofol concentration and the ERD/ERS.
Measured: 2 hours, during the experimentation
Detection ERS after median nerve stimulation
Investigators will test wether an ERS is present during propofol infusion at the effect-site concentrations of 0.5 µL/ml and 1.0 µL/mL.
Measured: 2 hours, during the experimentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Nov 2018
- Primary completion30 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ElectroencephalographyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Every subject will have an EEG recording in the absence of propofol, or during light sedation with propofol at an effect-site target concentration of 0.5 µg/mL and 1.0 µg/mL. Each subject will be his own control.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe GUERCI, M.D., PhD, Central Hospital, Nancy, France
- Investigators
- Sébastien Rimbert, Study chair, Institut National de Recherche en Informatique et en AutomatiquePhilippe GUERCI, MD, Principal investigator, CHRU de NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362775
- Sponsor's protocol ID
- PSS 2017/MOTANA-SCHMARTZ/MS
- Acronym
- MOTANA
- Status last verified
- Feb 2023
- First submitted
- 27 Nov 2017
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blokland YM, Farquhar JD, Mourisse J, Scheffer GJ, Lerou JG, Bruhn J. Towards a novel monitor of intraoperative awareness: selecting paradigm settings for a movement-based brain-computer interface. PLoS One. 2012;7(9):e44336. doi: 10.1371/journal.pone.0044336. Epub 2012 Sep 6.
PubMed 22970202Blokland Y, Farquhar J, Lerou J, Mourisse J, Scheffer GJ, Geffen GJ, Spyrou L, Bruhn J. Decoding motor responses from the EEG during altered states of consciousness induced by propofol. J Neural Eng. 2016 Apr;13(2):026014. doi: 10.1088/1741-2560/13/2/026014. Epub 2016 Feb 9.
PubMed 26859192Lindig-Leon C, Bougrain L. Comparison of sensorimotor rhythms in EEG signals during simple and combined motor imageries over the contra and ipsilateral hemispheres. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:3953-6. doi: 10.1109/EMBC.2015.7319259.
PubMed 26737159Rimbert S, Schmartz D, Bougrain L, Meistelman C, Baumann C, Guerci P. MOTANA: study protocol to investigate motor cerebral activity during a propofol sedation. Trials. 2019 Aug 28;20(1):534. doi: 10.1186/s13063-019-3596-9.
PubMed 31455386
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Analysis During Light Propofol Sedation
- ClinicalTrials.gov ID
- NCT03362775
- Acronym / sponsor ID
- MOTANA / PSS 2017/MOTANA-SCHMARTZ/MS
- Conditions
- Electroencephalography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Dec 2017 (actual)
- 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 hypothesis of this study is that propofol sedation does not affect the detectability of a movement intention in the EEG motor cortex signal. EEG signals will be recorded during the realization of intentional movements and movement intentions by the healthy volunteers, as well as during median nerve stimulation before and during propofol perfusion according to a target control infusion. (0 µg/mL; 0.5 µg/mL and 1 µg/mL).
Detailed description
During an anesthesia, 0.1 to 0.2% of patients have an unexpected per-operative awakening, with the risk to have serious psychological consequences.
During a per-operative awakening, one of the first reflex of the patient is to move, but this is often not possible due to the use of neuromuscular blocking agents during the surgical procedure.
It is possible to detect a movement intention by analyzing the motor cortex EEG signal in awake volunteers. The same signal is present during light, non-painful median nerve stimulation.
The aim of this study is to determine wether this EEG signal can still be detected during light sedation by propofol, a drug commonly used during anesthesia. The investigators will include healthy male volunteers, who will make real movements, imagine a movement and have median nerve stimulations before and during a propofol infusion. The propofol will be infused according to a target controlled infusion with a effect-site concentration of 0.5 µg/mL and 1.0 µg/mL. Primary outcome is the detectability of event related desynchronization and event related synchronization in the EEG signal in the presence of propofol compared to the recordings without propofol
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Every subject will have an EEG recording in the absence of propofol, or during light sedation with propofol at an effect-site target concentration of 0.5 µg/mL and 1.0 µg/mL. Each subject will be his own control.
| Arm | Type | Receives |
|---|---|---|
| All subjects | Other | Drug: PropofolEEG will be recorded in all subjects before (0.0 µL/mL) and during a target controlled infusion of propofol (0.5 µL/mL and 1.0 µL/mL). |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteers
- Male
- affiliated to French social security
- normal physical examination
- 22 < body mass index < 28
Key exclusion criteria (4 listed)
- Female
- allergy to propofol or one of the emulsion compounds (soja, egg)
- any pathology which may influence EEG recording or nerve conduction, such as diabetes, neuropathy, epilepsy, depression, psychotropic drug usage, drug usage)
- any allergic reaction associated with anesthesia
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 |
|---|---|---|
| PropofolTarget-controlled infusion of propofol with an effect-site concentration of 0.0 µL/mL; 0.5 µL/mL and 1.0 µL/mL. | Drug | All subjects |
Primary outcome
ERD/ERS amplitude
Time frame: 2 hours, during the experimentation
Amplitude of event-related synchronization (ERS) and event-related desynchronization (ERD) will be recorded within 2 seconds of each motor task (real movement, imaginary movement) as well as median nerve stimulation. This amplitude will be compared tio the value recorded in the absence of propofol.
2 secondary outcomes
Dose relationship between ERD/ERS and propofol concentration
Time frame: 2 hours, during the experimentation
Detection ERS after median nerve stimulation
Time frame: 2 hours, during the experimentation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Background: PubMed 22970202Blokland YM, Farquhar JD, Mourisse J, Scheffer GJ, Lerou JG, Bruhn J. Towards a novel monitor of intraoperative awareness: selecting paradigm settings for a movement-based brain-computer interface. PLoS One. 2012;7(9):e44336. doi: 10.1371/journal.pone.0044336. Epub 2012 Sep 6.
- Background: PubMed 26859192Blokland Y, Farquhar J, Lerou J, Mourisse J, Scheffer GJ, Geffen GJ, Spyrou L, Bruhn J. Decoding motor responses from the EEG during altered states of consciousness induced by propofol. J Neural Eng. 2016 Apr;13(2):026014. doi: 10.1088/1741-2560/13/2/026014. Epub 2016 Feb 9.
- Background: PubMed 26737159Lindig-Leon C, Bougrain L. Comparison of sensorimotor rhythms in EEG signals during simple and combined motor imageries over the contra and ipsilateral hemispheres. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:3953-6. doi: 10.1109/EMBC.2015.7319259.
- Derived from this study: PubMed 31455386Rimbert S, Schmartz D, Bougrain L, Meistelman C, Baumann C, Guerci P. MOTANA: study protocol to investigate motor cerebral activity during a propofol sedation. Trials. 2019 Aug 28;20(1):534. doi: 10.1186/s13063-019-3596-9.
- Individual participant dataSharing planned: No
Related trials for Electroencephalography
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
Active, not recruiting
Impact of Force Feedback in VR Training on EEG Biomarkers and Real-World Motor Performance
Motor Skills, Healthy Volunteer
Recruiting
The Effects of Midazolam, Dexmedetomidine, and Esketamine on Bispectral Index and Raw Electroencephalogram in Patients Under Propofol-Remifentanil Baseline Anesthesia
Depth of Anesthesia Monitoring, BIS-EEG
Recruiting
Processed Electroencephalography-guided General Anesthesia and Outcomes in Major Abdominal Surgery
Postoperative Acute Kidney Injury
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.
Sébastien Rimbert study chair
Institut National de Recherche en Informatique et en Automatique
Philippe GUERCI, MD principal investigator
CHRU de NANCY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Propofol in people with Electroencephalography, run by Central Hospital, Nancy, France at 1 site in France.
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 5 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 16 Feb 2023. 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 France. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Philippe Guerci, MD (+ 33 3 83 15 39 39, p.guerci@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ERD/ERS amplitude (time frame: 2 hours, during the experimentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03362775, which also lists 4 linked publications.
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 16 Feb 2023.