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EEG Analysis During Light Propofol Sedation (MOTANA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362775
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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).

Condition or disease Intervention/treatment Phase
Electroencephalography Drug: Propofol Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Masking Description: EEG will be electronically recorded and anonymised. The outcome assessor will analyse the EEG without knowledge of the propofol concentration.
Primary Purpose: Basic Science
Official Title: EEG Analysis During Light Propofol Sedation
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. ERD/ERS amplitude [ Time Frame: 2 hours, during the experimentation ]
    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.


Secondary Outcome Measures :
  1. Dose relationship between ERD/ERS and propofol concentration [ Time Frame: 2 hours, during the experimentation ]
    Investigators will analyze wether there is a relationship between the propofol concentration and the ERD/ERS.

  2. Detection ERS after median nerve stimulation [ Time Frame: 2 hours, during the experimentation ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362775


Contacts
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Contact: Philippe Guerci, MD + 33 3 83 15 39 39 p.guerci@chru-nancy.fr
Contact: Claude Meistelman, MD, PhD + 33 3 83 85 85 85 ext 54166 c.meistelman@chru-nancy.fr

Locations
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France
Department of Anesthesiology and Critical Care Medicine - University Hospital of Nancy Recruiting
Nancy, France, 54500
Contact: Philippe Guerci, MD         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Study Chair: Sébastien Rimbert Institut National de Recherche en Informatique et en Automatique
Principal Investigator: Philippe GUERCI, MD CHRU de NANCY
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03362775    
Other Study ID Numbers: PSS 2017/MOTANA-SCHMARTZ/MS
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics