Relationship Between the Depth of Anesthesia and Auditory Evoked Potentials (P3a)

NCT05283018 | Unknown

• 2 other identifiers: APHP2112872021-A02322-39
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The interest of perioperative cerebral monitoring and in particular electroencephalography (EEG) to reduce neurological and cognitive damage in surgery has been the subject of abundant research and corresponds to a crucial issue. There is increasing evidence to suggest that inadequate (overdosed) anesthesia for patient characteristics and intraoperative hemodynamic instability is associated with an increased risk of complications including postoperative cognitive dysfunction and postoperative mortality. However, these devices have many limitations in use, in particular their consideration of the muscle component of the electrical signal collected.There are other identifiable EEG signals that can be used to assess the depth of anesthesia, in particular auditory evoked potentials (AEPs). The so-called rough sound waves correspond to a formulation composed of the rapid repetition of acoustic segments, at a frequency of 30 to 150 Hz.This frequency (whether sound or light) induces a temporal activation that captures attention and provokes unpleasant sensations and avoidance strategies when perceived by a subject. This project aims at overcoming the interaction of the muscular electrical signal by evaluating the electrophysiological response (auditory evoked potentials) to particular sound stimuli, called "rough", thus underpinning the understanding of the mechanisms of neurosensory integration and attention during a state of loss of consciousness or altered consciousness. The hypothesis proposed for this study is the following: the P3a wave (positive wave collected on the EEG during auditory evoked potentials) is altered during general anesthesia, in frequency and amplitude, and thus is indicative of the depth of the anesthetic state.

Conditions

General Anesthesia

Keywords

Auditory Evoked Potentials; Electroencephalography Phase Synchronization; P3 Event-Related Potentials; Depth of anesthesia; Acoustic Stimulation

Outcome Measures

Primary Outcomes (4)

• Duration of the P3a subcomponent of the P300

  EEG monitoring of the P3a wave obtained by emission of rough sound signals: duration of P3a (ms) wave onset periods over four distinct periods: 1/baseline or during pre-oxygenation at FiO2 of 21% in awake patients; 2/ during anesthetic induction; 3/ deep sleep; 4/ recovery period.

  Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)

• P3a amplitude

  EEG monitoring of the P3a wave obtained by emission of rough sound signals: P3a amplitude (A in µV) over four distinct periods: 1/ baseline or during pre-oxygenation at FiO2 of 21% in awake patients; 2/ during anesthetic induction; 3/ deep sleep; 4/ recovery period.

  Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)

• P3a frequency

  EEG monitoring of the P3a wave obtained by emission of rough sound signals: P3a wave frequency (FP3 in Hz) over four distinct periods: 1/ baseline or during pre-oxygenation at FiO2 of 21% in awake patients; 2/ during anesthetic induction; 3/ deep sleep; 4/ recovery period.

  Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)

• Depth of anesthesia

  Depth of anesthesia measured by bispectral index (BIS, MASIMO, %) over four distinct periods: 1/ baseline or during pre-oxygenation at FiO2 of 21% in awake patients; 2/ during anesthetic induction; 3/ deep sleep; 4/ recovery period.

  Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)

Secondary Outcomes (5)

• Mean arterial blood pressure

  Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)

• Cerebral blood flow velocity (CFV)

  Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)

• Burst Suppression (BS)

  Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)

• Spectral Edge Frequency (SEF95)

  Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)

• Cerebral oxygen saturation

  Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)

Study Arms (1)

Surgery under general anesthesia

Patients undergoing urgent or scheduled surgery at Lariboisière Hospital

Device: Electroencephalogram recording; Other: Auditory stimulation; Device: Transcranial Doppler; Device: Near-infrared spectroscopy

Interventions

Electroencephalogram recording DEVICE

Brain function monitoring using a Sedline® module (Masimo corporation) to evaluate the state of the brain under anesthesia

Surgery under general anesthesia

Auditory stimulation OTHER

Monotonous sounds are sent via binaural headphones: a standard item and a distractor item (rough sound). Each stimulus lasts about 300 ms and they are separated by 1.5 to 2 seconds between them; the deviant sound/standard sound ratio is fixed between 1/5 and 1/6.

Surgery under general anesthesia

Transcranial Doppler DEVICE

Measurement of cerebral blood flow velocity (CFV) with use of Transcranial Doppler ultrasonography. For all patients, CFV (unit cm/s) will be collected over four distinct periods: 1/ baseline or during pre-oxygenation at inspired oxygen fraction (FiO2) of 21% in awake patients; 2/ during anesthetic induction; 3 /deep sleep; 4/ recovery period.

Surgery under general anesthesia

Near-infrared spectroscopy DEVICE

Continuous measurement of cerebral oxygen saturation (SO2) with Near-infrared spectroscopy (NIRS). For all patients, SO2 (%) will be collected over four distinct periods: 1/ baseline or during pre-oxygenation at FiO2 of 21% in awake patients; 2/ during anesthetic induction; 3 /deep sleep; 4/ recovery period.

Surgery under general anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients eligible for an outpatient or scheduled surgery procedure under general anesthesia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• INSERM UMR-942, Paris, France: collaborator
• Laboratoire de Mécanique des Solides, École polytechnique: collaborator
• M3DISIM Inria Université Paris-Saclay: collaborator

Study Sites (1)

AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care

Paris, 75010, France

RECRUITING

MeSH Terms

Interventions

Acoustic Stimulation; Ultrasonography, Doppler, Transcranial; Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Therapeutics; Sensory Art Therapies; Complementary Therapies; Physical Stimulation; Investigative Techniques; Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Joaquim MATEO, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Fabrice VALLEE, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joaquim MATEO, MD

CONTACT

+33 (0)1 49 95 83 74; joaquim.mateo@aphp.fr

Fabrice VALLEE, MD, PhD

CONTACT

+33 (0)1 49 95 80 71; fabrice.vallee@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

FR (1)