EEG Analysis During Light Propofol Sedation

NCT03362775 | Unknown Phase 1 DMC

• 1 other identifier: PSS 2017/MOTANA-SCHMARTZ/MS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Electroencephalography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dose relationship between ERD/ERS and propofol concentration

  2 hours, during the experimentation

• Detection ERS after median nerve stimulation

  2 hours, during the experimentation

Study Arms (1)

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).

Drug: Propofol

Interventions

Propofol DRUG

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

All subjects

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Department of Anesthesiology and Critical Care Medicine - University Hospital of Nancy

Nancy, 54500, France

RECRUITING

Related Publications (4)

• 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.

  PMID: 22970202 BACKGROUND

• 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.

  PMID: 26859192 BACKGROUND

• 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.

  PMID: 26737159 BACKGROUND

• 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.

  PMID: 31455386 DERIVED

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Sébastien Rimbert

  Institut National de Recherche en Informatique et en Automatique

  STUDY CHAIR

• Philippe GUERCI, MD

  CHRU de NANCY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Guerci, MD

CONTACT

+ 33 3 83 15 39 39; p.guerci@chru-nancy.fr

Claude Meistelman, MD, PhD

CONTACT

+ 33 3 83 85 85 85; c.meistelman@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: EEG will be electronically recorded and anonymised. The outcome assessor will analyse the EEG without knowledge of the propofol concentration.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ph

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 5, 2017
• Study Start: November 1, 2018
• Primary Completion: October 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)