Exploring how anesthesia depth affects brain responses to sound
Continuous Monitoring of the P3a Response During General Anesthesia Using the Rough Auditory Stimuli Coupled to the Analysis of Frontal EEG Signal
This study is testing how different levels of anesthesia affect brain responses to sound in patients having surgery, to find better ways to monitor their brain activity during the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05283018 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between the depth of general anesthesia and auditory evoked potentials (AEPs) using electroencephalography (EEG). It aims to improve perioperative cerebral monitoring to reduce neurological and cognitive complications associated with surgery. By analyzing EEG signals in response to auditory stimuli, the study seeks to identify more reliable indicators of anesthesia depth compared to current methods like the bispectral index. The research involves major patients undergoing scheduled surgeries and utilizes various monitoring techniques, including transcranial Doppler and near-infrared spectroscopy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for outpatient or elective surgeries requiring general anesthesia.
Not a fit: Patients under 18, those with pre-existing auditory impairments, severe cognitive impairments, or who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring techniques that enhance patient safety during surgery by reducing the risk of cognitive dysfunction and mortality.
How similar studies have performed: Other studies have shown promise in using EEG for monitoring anesthesia depth, but this specific approach utilizing auditory evoked potentials is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Major patients (≥ 18 years old) * Eligible for an outpatient or scheduled surgery procedure under general anesthesia * Patient who expressed his non-opposition to participation in this research Exclusion Criteria: * Patient under the age of 18 * Pre-existing auditory sensorineural impairment * Severe pre-existing cognitive impairment (preoperative mini-mental state examination MMSE \< 24) * Patient opposed to participation in the protocol * Pregnant woman * Patient under judicial protection measure * Patient without affiliation to a social security scheme * Patient benefiting from the State medical assistance (AME) programme
Where this trial is running
Paris
- AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care — Paris, France (Recruiting)
Study contacts
- Principal investigator: Fabrice VALLEE, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Joaquim MATEO, MD
- Email: joaquim.mateo@aphp.fr
- Phone: +33 (0)1 49 95 83 74
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.