Actively Recruiting

Early Phase 1
Age: 18Years - 81Years
MALE
NCT05272202

Investigation of Cerebral Motor Activity Modulations Following Median Nerve Stimulation During General Anaesthesia

Led by Brugmann University Hospital · Updated on 2023-02-16

30

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Investigation of Cerebral Motor Activity Modulations Following Median Nerve Stimulation During General Anaesthesia

Who Can Participate

Age: 18Years - 81Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients older than 18 years and younger than 81 years
  • Right-handed individuals
  • Scheduled for surgery using intravenous anesthesia with propofol concentration target
Not Eligible

You will not qualify if you...

  • Allergy to propofol, soy, or peanuts
  • Body Mass Index less than 20 or greater than 30
  • Pregnant or breastfeeding women
  • Adults unable to provide consent
  • Medical or surgical history interfering with median nerve stimulation or EEG signals (e.g., diabetes, polyneuropathy, neurodegenerative diseases, epilepsy, brain surgery)
  • History of injury to the right median nerve
  • Amputation of the upper right limb
  • Inability to wear an EEG helmet
  • Addiction

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU Brugmann

Brussels, Belgium, 1020

Actively Recruiting

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Research Team

D

Denis Schmartz, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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