Status:

RECRUITING

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

Lead Sponsor:

Brugmann University Hospital

Conditions:

Accidental Awareness During General Anesthesia

Eligibility:

MALE

18-81 years

Phase:

EARLY_PHASE1

Brief 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). Actuall...

Eligibility Criteria

Inclusion

  • Patients \>18 years and \<81 years
  • Right-handed
  • Programmed for surgery with the use of an intravenous anesthesia with a propofol concentration objective

Exclusion

  • Allergy to propofol, soy or peanuts
  • BMI\<20 or \>30
  • Pregnant or breastfeeding women
  • Adult unable to give consent
  • Medical or surgical history that may interfere with median nerve stimulation or the obtention of the EEG signal (for example: diabetes, polyneuropathy, central neurodegenerative disease, epilepsy, brain surgery)
  • History of right median nerve injury
  • Amputation of the upper right limb
  • Impossibility of affixing an EEG helmet
  • Addiction

Key Trial Info

Start Date :

January 15 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT05272202

Start Date

January 15 2023

End Date

December 31 2026

Last Update

February 16 2023

Active Locations (1)

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1

CHU Brugmann

Brussels, Belgium, 1020