Relationship Between Sleep EEG, Intraoperative EEG and Postoperative Cognitive Dysfunction

NCT04481347 | Unknown

• 2 other identifiers: APHP2000372019-A03206-51
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Dysfunction

Keywords

postoperative cognitive dysfunction; depth of anesthesia; brain fragility; electrographic suppression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Burst suppression duration

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

• Variations in alpha power on sleep EEG

  Change between day -1 and day 5

• Spindle amplitude on sleep EEG

  Change between day -1 and day 5

• Spindle frequency on sleep EEG

  Change between day -1 and day 5

Study Arms (1)

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.

Device: Sleep EEG recording using a DREEM® headband; Other: Montreal Cognitive Assessment (MoCA); Device: Intraoperative EEG recording using a Sedline® monitoring

Interventions

Sleep EEG recording using a DREEM® headband DEVICE

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

Patients undergoing general anesthesia

Montreal Cognitive Assessment (MoCA) OTHER

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

Patients undergoing general anesthesia

Intraoperative EEG recording using a Sedline® monitoring DEVICE

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

Patients undergoing general anesthesia

Eligibility Criteria

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

Study Population

Patients eligible for a non-emergency scheduled interventional neuroradiology procedure or surgery performed under general anesthesia.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• INSERM UMR-942, Paris, France: collaborator
• LMS Ecole polytechnique and M3DISIM, Inria: collaborator

Study Sites (1)

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

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Joaquim MATEO, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Fabrice VALLEE, MD

  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

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: June 23, 2020
• First Posted: July 22, 2020
• Study Start: July 15, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

FR (1)