Accidental Awareness During General AnesthesiaEarly Phase 1NCT05272202
Investigation of Cerebral Motor Activity Modulations Following Median Nerve Stimulation During General Anaesthesia
A Early Phase 1 study testing Propofol, Median nerve stimulation and EEG measurements in people with Accidental Awareness During General Anesthesia, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
Accidental Awareness during General Anesthesia (AAGA) occurs in 1-2% of high-risk practice patients and is a cause of severe psychological trauma, termed post-traumatic stress disorder (PTSD). Actually, no monitoring techniques can accurately predict or detect an AAGA. Read more about this study
- Who is it for?
- Ages 18 to 81 years, men only
- Conditions the study is for
- Accidental Awareness During General Anesthesia
- What is being tested?
- Propofol, Median nerve stimulation and EEG measurements
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jan 2023to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 81 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >18 years and <81 years
- Right-handed
- Programmed for surgery with the use of an intravenous anesthesia with a propofol concentration objective
Who cannot join
- Allergy to propofol, soy or peanuts
- BMI<20 or >30
- Pregnant or breastfeeding women
- Adult unable to give consent
- Medical or surgical history that may interfere with median nerve stimulation or the obtention of the EEG signal (for example: diabetes, polyneuropathy, central neurodegenerative disease, epilepsy, brain surgery)
- History of right median nerve injury
Show all 9Show fewer
- Amputation of the upper right limb
- Impossibility of affixing an EEG helmet
- Addiction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHU Brugmann
Brussels, 1020
Denis Schmartz, MD, +3224773996, denis.schmartz@chu-brugmann.be
About this study
Official title: Study of Modulations of Motor Brain Activity Following Stimulation of the Median Nerve During General Anesthesia
Accidental Awareness during General Anesthesia (AAGA) occurs in 1-2% of high-risk practice patients and is a cause of severe psychological trauma, termed post-traumatic stress disorder (PTSD). Actually, no monitoring techniques can accurately predict or detect an AAGA. Since the first reflex for a patient during an AAGA is to move, a brain-computer interface (BCI) based on the detection of an intention of movement would be conceivable to alert the anesthetist. The investigators previously showed that median nerve stimulation (MNS) could be the keystone of a BCI specialized in the detection of movement intention. Indeed, based on these previous results, the investigators can envisage a routine system where the patient would be stimulated at the median nerve position, while a BCI device would analyze the event-related desynchronization (ERD) and event-related synchronization (ERS) modulations in the motor cortex to check whether the patient is intending to move or not. According to the investigator's knowledge, no published studies have investigated the detection of EEG patterns in relation to peripheral nerve stimulation over the sensorimotor cortex during general anesthesia. The main objective of this study is to describe the changes in terms of ERD and ERS modulations, in the EEG signal over the motor cortex, during general anesthesia with propofol, while a median nerve stimulation is performed.
STIM-MOTANA is an interventional and prospective study conducted in patients scheduled for surgery under general anesthesia, involving EEG measurements and median nerve stimulation. In this study, 30 patients will undergo surgery under total intravenous anesthesia using a propofol target-controlled infusion pump. The rest of the anesthetic protocol will be at the discretion of the anesthesiologist in charge. Changes in ERD and ERS during median nerve stimulation according to the various propofol concentrations will be continuously monitored by an EEG amplifier. Pre- and post-injection comparisons of propofol will be performed by paired series tests. After surgery, patients will have a gradual decrease of propofol at different effect-site concentrations (from 4.0 μg/ml to 2.0 μg/ml, in increments of 0.5 μg/ml).
- Being tested
- Propofol, Median nerve stimulation, EEG measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
STIM-MOTANA is an interventional and prospective study conducted in patients scheduled for surgery under general anesthesia, involving EEG measurements and median nerve stimulation. In this study, 30 patients will undergo surgery under total intravenous anesthesia using a propofol target-controlled infusion pump. The rest of the anesthetic protocol will be at the discretion of the anesthesiologist in charge. After surgery, patients will have a gradual decrease of propofol at different effect-site concentrations (from 4.0 μg/ml to 2.0 μg/ml, in increments of 0.5 μg/ml).
Median nerve stimulationDevice
The right-hand median nerve will be stimulated in the same way as for measurement with a conduction velocity or for an evoked potential. Two stimulation electrodes will be placed on the right-hand wrist according to the standards.The stimulation is transcutaneous and painless using the specific Micromed device Sd Ltm Stim Energy (Micromed, Mˆacon, France). The stimulus intensity will range between 3 and 14 mA. The stimulation duration will be 100 ms with a frequency of 0.1 Hz.
EEG measurementsDevice
Changes in ERD and ERS patterns during median nerve stimulation according to the various propofol concentrations will be continuously monitored by an EEG amplifier. EEG signals will be acquired using the OpenViBE platform with a Biosemi Active Two 64-channel EEG system, arranged in the Biosemi's ABC system covering the entire scalp at 2048 Hz. Among all recorded sites, some of the electrodes will be localized around the primary motor cortex, the motor cortex, the somatosensory cortex, and the occipital cortex.
| Study group | Role | What they receive |
|---|---|---|
| Median nerve stimulation | Experimental | Not described Receives: Drug: Propofol; Device: Median nerve stimulation; Device: EEG measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of the ERD (event-related desynchronization)/ERS (event- related synchronization)
The main evaluation outcome will be the amplitude of the ERD (event-related desynchronization)/ERS (event- related synchronization) after median nerve stimulation, within 4 s of the stimulation, at various propofol concentrations. This amplitude will be calculated using a baseline taken before each stimulation. The amplitudes of the ERD and ERS will be extracted. The ERDs and ERSs will be displayed from the time each stimulation is performed until 4 s after the stimulation is completed.
Measured: From the time each stimulation is performed until 4 seconds after the stimulation is completed.
Secondary outcomes (4)
Detection of ERD patterns via new machine-learning algorithms (percent of correct detection)
Verify the detection of ERD patterns via new machine-learning algorithms at different propofol concentrations. ERD patterns will be analysed manually, as well as automated by a machine-learning algorythm. Endpoint will be the percentage (%) of correctly identified ERD pattern by the algorythm.
Measured: From the time each stimulation is performed until 4 seconds after the stimulation is completed.
Modulation of ERD patterns by anesthetics drugs. Percentage of variation in amplitude.
Another secondary criteria will to describe how the ERD generated by an MNS would be modulated by anesthetics drugs. Amplitude of ERD patterns will be recorded (microV) and the effect of anesthetic drugs on this amplitude will be described as percentage change.
Measured: From the time each stimulation is performed until 4 seconds after the stimulation is completed.
Detection of ERS patterns via new machine-learning algorithms (percentage of correct detection)
Verify the detection of ERS patterns via new machine-learning algorithms at different propofol concentrations. ERS patterns will be analysed manually, as well as automated by a machine-learning algorythm. Endpoint will be the percentage (%) of correctly identified ERS pattern by the algorythm.
Measured: From the time each stimulation is performed until 4 seconds after the stimulation is completed.
Modulation of ERS patterns by anesthetics drugs via new machine-learning algorithms (percentage change in amplitude)
Another secondary criteria will to describe how the ERS generated by an MNS would be modulated by anesthetics drugs. Amplitude of ERS patterns will be recorded (microV) and the effect of anesthetic drugs on this amplitude will be described as percentage change.
Measured: From the time each stimulation is performed until 4 seconds after the stimulation is completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start15 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental Awareness During 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis SCHMARTZ, Brugmann University Hospital
- Investigators
- Denis Schmartz, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272202
- Sponsor's protocol ID
- STIM-MOTANA
- Status last verified
- Feb 2023
- First submitted
- 11 Jan 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rimbert S, Lelarge J, Guerci P, Bidgoli SJ, Meistelman C, Cheron G, Cebolla Alvarez AM, Schmartz D. Detection of Motor Cerebral Activity After Median Nerve Stimulation During General Anesthesia (STIM-MOTANA): Protocol for a Prospective Interventional Study. JMIR Res Protoc. 2023 Feb 2;12:e43870. doi: 10.2196/43870.
PubMed 36729587
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
- Study of Modulations of Motor Brain Activity Following Stimulation of the Median Nerve During General Anesthesia
- ClinicalTrials.gov ID
- NCT05272202
- Acronym / sponsor ID
- STIM-MOTANA
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Mar 2022 (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.
Accidental Awareness during General Anesthesia (AAGA) occurs in 1-2% of high-risk practice patients and is a cause of severe psychological trauma, termed post-traumatic stress disorder (PTSD). Actually, no monitoring techniques can accurately predict or detect an AAGA. Since the first reflex for a patient during an AAGA is to move, a brain-computer interface (BCI) based on the detection of an intention of movement would be conceivable to alert the anesthetist. The investigators previously showed that median nerve stimulation (MNS) could be the keystone of a BCI specialized in the detection of movement intention. Indeed, based on these previous results, the investigators can envisage a routine system where the patient would be stimulated at the median nerve position, while a BCI device would analyze the event-related desynchronization (ERD) and event-related synchronization (ERS) modulations in the motor cortex to check whether the patient is intending to move or not. According to the investigator's knowledge, no published studies have investigated the detection of EEG patterns in relation to peripheral nerve stimulation over the sensorimotor cortex during general anesthesia. The main objective of this study is to describe the changes in terms of ERD and ERS modulations, in the EEG signal over the motor cortex, during general anesthesia with propofol, while a median nerve stimulation is performed.
STIM-MOTANA is an interventional and prospective study conducted in patients scheduled for surgery under general anesthesia, involving EEG measurements and median nerve stimulation. In this study, 30 patients will undergo surgery under total intravenous anesthesia using a propofol target-controlled infusion pump. The rest of the anesthetic protocol will be at the discretion of the anesthesiologist in charge. Changes in ERD and ERS during median nerve stimulation according to the various propofol concentrations will be continuously monitored by an EEG amplifier. Pre- and post-injection comparisons of propofol will be performed by paired series tests. After surgery, patients will have a gradual decrease of propofol at different effect-site concentrations (from 4.0 μg/ml to 2.0 μg/ml, in increments of 0.5 μg/ml).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Median nerve stimulation | Experimental | Drug: Propofol, Device: Median nerve stimulation, Device: EEG measurements |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients >18 years and <81 years
- Right-handed
- Programmed for surgery with the use of an intravenous anesthesia with a propofol concentration objective
Key exclusion criteria (9 listed)
- Allergy to propofol, soy or peanuts
- BMI<20 or >30
- Pregnant or breastfeeding women
- Adult unable to give consent
- Medical or surgical history that may interfere with median nerve stimulation or the obtention of the EEG signal (for example: diabetes, polyneuropathy, central neurodegenerative disease, epilepsy, brain surgery)
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 |
|---|---|---|
| PropofolSTIM-MOTANA is an interventional and prospective study conducted in patients scheduled for surgery under general anesthesia, involving EEG measurements and median nerve stimulation. In this study, 30 patients will undergo surgery under total intravenous anesthesia using a propofol target-controlled infusion pump. The rest of the anesthetic protocol will be at the discretion of the anesthesiologist in charge. After surgery, patients will have a gradual decrease of propofol at different effect-site concentrations (from 4.0 μg/ml to 2.0 μg/ml, in increments of 0.5 μg/ml). | Drug | Median nerve stimulation |
| Median nerve stimulationThe right-hand median nerve will be stimulated in the same way as for measurement with a conduction velocity or for an evoked potential. Two stimulation electrodes will be placed on the right-hand wrist according to the standards.The stimulation is transcutaneous and painless using the specific Micromed device Sd Ltm Stim Energy (Micromed, Mˆacon, France). The stimulus intensity will range between 3 and 14 mA. The stimulation duration will be 100 ms with a frequency of 0.1 Hz. | Device | Median nerve stimulation |
| EEG measurementsChanges in ERD and ERS patterns during median nerve stimulation according to the various propofol concentrations will be continuously monitored by an EEG amplifier. EEG signals will be acquired using the OpenViBE platform with a Biosemi Active Two 64-channel EEG system, arranged in the Biosemi's ABC system covering the entire scalp at 2048 Hz. Among all recorded sites, some of the electrodes will be localized around the primary motor cortex, the motor cortex, the somatosensory cortex, and the occipital cortex. | Device | Median nerve stimulation |
Primary outcome
Amplitude of the ERD (event-related desynchronization)/ERS (event- related synchronization)
Time frame: From the time each stimulation is performed until 4 seconds after the stimulation is completed.
The main evaluation outcome will be the amplitude of the ERD (event-related desynchronization)/ERS (event- related synchronization) after median nerve stimulation, within 4 s of the stimulation, at various propofol concentrations. This amplitude will be calculated using a baseline taken before each stimulation. The amplitudes of the ERD and ERS will be extracted. The ERDs and ERSs will be displayed from the time each stimulation is performed until 4 s after the stimulation is completed.
4 secondary outcomes
Detection of ERD patterns via new machine-learning algorithms (percent of correct detection)
Time frame: From the time each stimulation is performed until 4 seconds after the stimulation is completed.
Modulation of ERD patterns by anesthetics drugs. Percentage of variation in amplitude.
Time frame: From the time each stimulation is performed until 4 seconds after the stimulation is completed.
Detection of ERS patterns via new machine-learning algorithms (percentage of correct detection)
Time frame: From the time each stimulation is performed until 4 seconds after the stimulation is completed.
Modulation of ERS patterns by anesthetics drugs via new machine-learning algorithms (percentage change in amplitude)
Time frame: From the time each stimulation is performed until 4 seconds after the stimulation is completed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 36729587Rimbert S, Lelarge J, Guerci P, Bidgoli SJ, Meistelman C, Cheron G, Cebolla Alvarez AM, Schmartz D. Detection of Motor Cerebral Activity After Median Nerve Stimulation During General Anesthesia (STIM-MOTANA): Protocol for a Prospective Interventional Study. JMIR Res Protoc. 2023 Feb 2;12:e43870. doi: 10.2196/43870.
- Individual participant dataSharing planned: No
Related trials for Accidental Awareness During General Anesthesia
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Accidental Awareness During General Anesthesia
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.
Denis Schmartz, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Propofol, Median nerve stimulation and EEG measurements in people with Accidental Awareness During General Anesthesia, run by Brugmann University Hospital at 1 site in Belgium.
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 3 inclusion and 9 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: looking for participants now, 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 Belgium. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denis Schmartz, MD (3224773734, Denis.SCHMARTZ@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of the ERD (event-related desynchronization)/ERS (event- related synchronization) (time frame: From the time each stimulation is performed until 4 seconds after the stimulation is completed.). 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 NCT05272202, which also lists 1 linked publication.
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.