Clinical trial NCT03362775: EEG Analysis During Light Propofol Sedation
Official title: EEG Analysis During Light Propofol Sedation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Electroencephalography
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief 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 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

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Male
* affiliated to French social security
* normal physical examination
* 22 \< body mass index \< 28

Exclusion Criteria:

* 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

Primary outcomes:
measure: ERD/ERS amplitude
timeFrame: 2 hours, during the experimentation
Secondary outcomes:
measure: Dose relationship between ERD/ERS and propofol concentration
timeFrame: 2 hours, during the experimentation
measure: Detection ERS after median nerve stimulation
timeFrame: 2 hours, during the experimentation
Other outcomes:
Locations:
city: Nancy
country: France
facility: Department of Anesthesiology and Critical Care Medicine - University Hospital of Nancy
Study officials:
affiliation: Institut National de Recherche en Informatique et en Automatique
name: Sébastien Rimbert
role: STUDY_CHAIR
affiliation: CHRU de NANCY
name: Philippe GUERCI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Blokland 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.
citation: Lindig-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.
citation: Rimbert 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.