Postoperative Cognitive Dysfunction Clinical Trial
— SOMEDYSPOOfficial title:
Relationship Between Sleep EEG, Intraoperative EEG and Postoperative Cognitive Dysfunction
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | INSERM UMR-942, Paris, France, LMS Ecole polytechnique and M3DISIM, Inria |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Early postoperative cognitive dysfunction | Score obtained following evaluation of the patient's cognitive function using the Montreal Cognitive Assessment questionnaire MoCA (0-30; higher score indicates better performance) | Change between day -1 and day 5 | |
Secondary | Burst suppression duration | For all patients the values of Burst Suppression (in % of time) will be collected from frontal electrodes montage (Fp1, Fp2, F7, F8) during the total anesthesia period (induction and hypnotic periods) | Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day) | |
Secondary | Variations in alpha power on sleep EEG | Variations in alpha power (in Decibel, Db) on the pre-operative and post-operative sleep EEG | Change between day -1 and day 5 | |
Secondary | Spindle amplitude on sleep EEG | Spindle amplitude (in Decibel, Db) on preoperative and postoperative sleep EEG | Change between day -1 and day 5 | |
Secondary | Spindle frequency on sleep EEG | Spindle frequency (in Hertz, Hz) on preoperative and postoperative sleep EEG | Change between day -1 and day 5 |
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