Relationship Between Sleep EEG, Intraoperative EEG and Postoperative Cognitive Dysfunction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Early postoperative cognitive dysfunction
Study Overview
Brief Summary
The challenge of new recommendations and better adapted practices is pushing to operate patients who are getting older and more fragile. In this context, there is an inevitable increase in the risks associated with care and in particular perioperative neurological complications, of which postoperative cognitive dysfunction (POCD) is the most common.
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.
From the literature and preliminary results obtained in our clinical research unit, it appears that there is also a relationship between certain characteristics of the peroperative EEG (signal strength and burst suppression) and the occurrence of postoperative cognitive dysfunction (PCOD).
In this context, quantitative analysis of the preoperative sleep EEG and the EEG obtained during general anesthesia could allow the identification of a simple to use biomarker of susceptibility or fragility. To our knowledge, there is no preoperative evaluation strategy using EEG analysis to detect a predisposition to POCD.
The main goal of this observational clinical study is to extend the traditional use of per-operative EEG with pre-operative and post-operative sleep EEG for the detection and prediction of early post-operative cognitive dysfunction.
Detailed Description
The interest of perioperative brain monitoring to reduce neurological and cognitive damage in surgery has been the subject of much research and corresponds to a crucial issue.
The notion of quantitative EEG covers all the electrical signal processing techniques (fast Fourier transformation, evoked potentials, EEG mapping, etc.) made possible through the digitization of EEG data and the development of software to process these signals. In this context, EEG-derived indices have been set up to monitor hypnosis during general anesthesia. Between 0 (deep hypnosis) and 100 (awakening), the Bispectral Index (BIS) integrates in its calculation the percentage of fast waves, the degree of wave synchronization and the periods of EEG suppression (or "Burst suppression") and allows an adaptation of the dosage of anesthetic products according to its value.
Avoiding too deep anesthesia through neuro-monitoring could help to reduce postoperative delirium by reducing the burst suppression pattern.
Pre-operative cognitive status assessment :
The investigators observe a great delay in the means implemented to have an objective evaluation of cognitive disorders in preoperative care.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Major patients (≥ 18 years )
- •Eligible for an interventional radiology procedure or surgery under general anesthesia
- •Patients informed and having expressed their non-opposition to participation in this research
Exclusion Criteria
- •Patients under 18 years old
- •Severe pre-existing cognitive impairment (preoperative mini-mental state examination (MMSE) < 24)
- •Patient opposed to protocol participation
- •Pregnant woman
- •Patient under judicial protection
- •Patient without affiliation to a social security scheme
- •Emergency procedure
Arms & Interventions
Patients undergoing general anesthesia
Patients eligible for interventional neuroradiology or surgery performed under general anesthesia. Patients will be included if they are admitted for a non-emergency scheduled procedure.
Intervention: Sleep EEG recording using a DREEM® headband (Device)
Patients undergoing general anesthesia
Patients eligible for interventional neuroradiology or surgery performed under general anesthesia. Patients will be included if they are admitted for a non-emergency scheduled procedure.
Intervention: Montreal Cognitive Assessment (MoCA) (Other)
Patients undergoing general anesthesia
Patients eligible for interventional neuroradiology or surgery performed under general anesthesia. Patients will be included if they are admitted for a non-emergency scheduled procedure.
Intervention: Intraoperative EEG recording using a Sedline® monitoring (Device)
Outcomes
Primary Outcomes
Early postoperative cognitive dysfunction
Time Frame: Change between day -1 and day 5
Score obtained following evaluation of the patient's cognitive function using the Montreal Cognitive Assessment questionnaire MoCA (0-30; higher score indicates better performance)
Secondary Outcomes
- Burst suppression duration(Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day))
- Spindle amplitude on sleep EEG(Change between day -1 and day 5)
- Spindle frequency on sleep EEG(Change between day -1 and day 5)
- Variations in alpha power on sleep EEG(Change between day -1 and day 5)