EEG Analysis During Light Propofol Sedation (MOTANA)

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).

Study Overview

• Status: Recruiting
• Conditions: Electroencephalography
• Intervention / Treatment: Drug: Propofol

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Philippe Guerci, MD; Phone Number: + 33 3 83 15 39 39; Email: p.guerci@chru-nancy.fr
• Study Contact Backup: Name: Claude Meistelman, MD, PhD; Phone Number: 54166 + 33 3 83 85 85 85; Email: c.meistelman@chru-nancy.fr

Study Locations

• France
  • Nancy, France, 54500
    • Recruiting
    • Department of Anesthesiology and Critical Care Medicine - University Hospital of Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 28 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All subjects; 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Study Chair: Sébastien Rimbert, Institut National de Recherche en Informatique et en Automatique; Principal Investigator: Philippe GUERCI, MD, CHRU de Nancy

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): October 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: PSS 2017/MOTANA-SCHMARTZ/MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No