Study of Modulations of Motor Brain Activity Following Stimulation of the Median Nerve During General Anesthesia

Who is this study for? Patients with Accidental Awareness During General Anesthesia
What treatments are being studied? Propofol+Median Nerve Stimulation+EEG Measurements
Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

Accidental Awareness during General Anesthesia (AAGA) occurs in 1-2% of high-risk practice patients and is a cause of severe psychological trauma, termed post-traumatic stress disorder (PTSD). Actually, no monitoring techniques can accurately predict or detect an AAGA. Since the first reflex for a patient during an AAGA is to move, a brain-computer interface (BCI) based on the detection of an intention of movement would be conceivable to alert the anesthetist. The investigators previously showed that median nerve stimulation (MNS) could be the keystone of a BCI specialized in the detection of movement intention. Indeed, based on these previous results, the investigators can envisage a routine system where the patient would be stimulated at the median nerve position, while a BCI device would analyze the event-related desynchronization (ERD) and event-related synchronization (ERS) modulations in the motor cortex to check whether the patient is intending to move or not. According to the investigator's knowledge, no published studies have investigated the detection of EEG patterns in relation to peripheral nerve stimulation over the sensorimotor cortex during general anesthesia. The main objective of this study is to describe the changes in terms of ERD and ERS modulations, in the EEG signal over the motor cortex, during general anesthesia with propofol, while a median nerve stimulation is performed. STIM-MOTANA is an interventional and prospective study conducted in patients scheduled for surgery under general anesthesia, involving EEG measurements and median nerve stimulation. In this study, 30 patients will undergo surgery under total intravenous anesthesia using a propofol target-controlled infusion pump. The rest of the anesthetic protocol will be at the discretion of the anesthesiologist in charge. Changes in ERD and ERS during median nerve stimulation according to the various propofol concentrations will be continuously monitored by an EEG amplifier. Pre- and post-injection comparisons of propofol will be performed by paired series tests. After surgery, patients will have a gradual decrease of propofol at different effect-site concentrations (from 4.0 μg/ml to 2.0 μg/ml, in increments of 0.5 μg/ml).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 81
Healthy Volunteers: f
View:

• Patients \>18 years and \<81 years

• Right-handed

• Programmed for surgery with the use of an intravenous anesthesia with a propofol concentration objective

Locations
Other Locations
Belgium
CHU Brugmann
RECRUITING
Brussels
Contact Information
Primary
Denis Schmartz, MD
Denis.SCHMARTZ@chu-brugmann.be
3224773734
Time Frame
Start Date: 2023-01-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Median nerve stimulation
Related Therapeutic Areas
Sponsors
Leads: Brugmann University Hospital

This content was sourced from clinicaltrials.gov