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TERMINATED
NCT04481347

Relationship Between Sleep EEG, Intraoperative EEG and Postoperative Cognitive Dysfunction

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

66

Start Date

2020-07-15

Completion Date

2022-02-21

Last Updated

2026-09-22

Healthy Volunteers

No

Interventions

DEVICE

Sleep EEG recording using a DREEM® headband

Sleep EEG recording using a Dreem® headband (Rythm, Paris, France), an EEG recording device adapted to sleep conditions and completely non-invasive

OTHER

Montreal Cognitive Assessment (MoCA)

Neuropsychological assessment using the The Montreal Cognitive Assessment (MoCA) questionnaire to detect postoperative cognitive dysfunction

DEVICE

Intraoperative EEG recording using a Sedline® monitoring

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

Locations (1)

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

Paris, France