EEG Analysis During Light Propofol Sedation (MOTANA)
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|ClinicalTrials.gov Identifier: NCT03362775|
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : August 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Electroencephalography||Drug: Propofol||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
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).
Target-controlled infusion of propofol with an effect-site concentration of 0.0 µL/mL; 0.5 µL/mL and 1.0 µL/mL.
- 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.
- 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.
- 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.
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
|Contact: Philippe Guerci, MD||+ 33 3 83 15 39 firstname.lastname@example.org|
|Contact: Claude Meistelman, MD, PhD||+ 33 3 83 85 85 85 ext email@example.com|
|Department of Anesthesiology and Critical Care Medicine - University Hospital of Nancy||Recruiting|
|Nancy, France, 54500|
|Contact: Philippe Guerci, MD|
|Study Chair:||Sébastien Rimbert||Institut National de Recherche en Informatique et en Automatique|
|Principal Investigator:||Philippe GUERCI, MD||CHRU de NANCY|