EEG Analysis During Light Propofol Sedation

Electroencephalography Clinical Trial

— MOTANA  

Official title:

EEG Analysis During Light Propofol Sedation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03362775
• Other study ID #: PSS 2017/MOTANA-SCHMARTZ/MS
• Status: Recruiting
• Phase: Phase 1
• Start date: November 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Central Hospital, Nancy, France
• Contact: Philippe Guerci, MD
• Phone: + 33 3 83 15 39 39
• Email: p.guerci[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 before and during propofol perfusion according to a target control infusion. (0 µg/mL; 0.5 µg/mL and 1 µg/mL).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 28 Years

Eligibility

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

Related Conditions & MeSH terms

• Electroencephalography

Intervention

Drug:
• Propofol
Target-controlled infusion of propofol with an effect-site concentration of 0.0 µL/mL; 0.5 µL/mL and 1.0 µL/mL.

Locations

Country	Name	City	State
France	Department of Anesthesiology and Critical Care Medicine - University Hospital of Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 hours, during the experimentation
Secondary	Dose relationship between ERD/ERS and propofol concentration	Investigators will analyze wether there is a relationship between the propofol concentration and the ERD/ERS.	2 hours, during the experimentation
Secondary	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.	2 hours, during the experimentation