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New treatment option for Accidental Awareness During General Anesthesia
Official title Investigation of Cerebral Motor Activity Modulations Following Median Nerve Stimulation During General Anaesthesia
ClinicalTrials.gov ID: NCT05272202
What this study is testing
What is Propofol?
Propofol is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for accidental awareness during general anesthesia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 81, men only
You may be able to join if
- Patients \>18 years and \<81 years
- Right-handed
- Programmed for surgery with the use of an intravenous anesthesia with a propofol concentration objective
You likely can't join if
- Allergy to propofol, soy or peanuts
- BMI\ 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...
- History of right median nerve injury
See the full eligibility criteria
- Patients \>18 years and \<81 years
- Right-handed
- Programmed for surgery with the use of an intravenous anesthesia with a propofol concentration objective
- Allergy to propofol, soy or peanuts
- BMI\ 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
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 81 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.