Intraoperative Diagnosis of Neurocognitive Complications Via Electroencephalographic Analysis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFederal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology

About this trial

Postoperative neurocognitive disorders (PND) are serious and common complications after surgery, especially in elderly patients. These disorders can affect cognitive functions for years, deteriorating quality of life and increasing hospital stays and medical costs. Diagnosing PND is challenging due to their varied manifestations, such as memory and attention problems, and the lack of standardized criteria and biomarkers.

One well-studied form of PND is postoperative delirium (POD). According to the ICD-10, POD is an organic cerebral syndrome characterized by disturbances in consciousness, attention, perception, and other cognitive functions. Researchers suggest that POD development involves a combination of predisposing and precipitating factors.

Electroencephalography (EEG) has been used in anesthesiology to assess anesthesia depth and intraoperative awareness. Modern EEG analysis methods, like spectral analysis, offer new ways to evaluate patients' neurophysiological states. Studies show that EEG monitoring can predict complications such as intraoperative stroke and delirium, particularly in cardiothoracic and neurosurgical operations.

The relationship between EEG patterns and POD is not well understood. Specific EEG patterns may indicate the risk of POD, aiding in the identification of risk factors and prevention methods. This could help anesthesiologists and surgeons optimize their approaches, reducing the risk of cognitive complications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Scheduled non-cardiac surgery of intermediate or high risk

General anesthesia using inhalational anesthetics

Informed consent from the patient to participate in the study

Disqualifiers

Preoperative MMSE score less than 20 points

History of any mental illness

Use of psychotropic drugs within 1 month prior to inclusion in the study

Presence of neuromuscular diseases

Trial population

Patients scheduled for non-cardiac surgery of intermediate to high risk

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Intraoperative electroencephalography

    Device

    EEG recording will be performed using the standard 16-electrode configuration according to the international "10-20" system. During the recording, electrode impedances will be maintained at a level not exceeding 5 kilo-ohms.

Treatment groups

265 Participants
are divided into 1 treatment group
Group A: Non-cardiac surgery1 intervention

Trial outcomes

Primary outcomes

1

Prognostic value of mean intraoperative alpha rhythm power for the development of postoperative delirium

The prognostic value assessment is performed using the area under the ROC curve (AUROC). The value ranges from 0.5 to 1.0. The closer the AUROC value is to one, the higher the prognostic capability of the electroencephalography.

Time frame
Through study completion, an average of 3 year
2

Prognostic value of mean intraoperative alpha rhythm power for the development of early postoperative neurocognitive disorders

The prognostic value assessment is performed using the area under the ROC curve (AUROC). The value ranges from 0.5 to 1.0. The closer the AUROC value is to one, the higher the prognostic capability of the electroencephalography.

Time frame
Through study completion, an average of 3 year
3

Prognostic value of mean intraoperative alpha rhythm power for the development of intraoperative silent brain infarction

The prognostic value assessment is performed using the area under the ROC curve (AUROC). The value ranges from 0.5 to 1.0. The closer the AUROC value is to one, the higher the prognostic capability of the electroencephalography.

Time frame
Through study completion, an average of 3 year

Secondary outcomes

1

Prognostic value of maximum intraoperative alpha rhythm power for the development of postoperative delirium

The prognostic value assessment is performed using the area under the ROC curve (AUROC). The value ranges from 0.5 to 1.0. The closer the AUROC value is to one, the higher the prognostic capability of the electroencephalography.

Time frame
Through study completion, an average of 3 year
2

Prognostic value of maximum intraoperative alpha rhythm power for the development of early postoperative neurocognitive disorders

The prognostic value assessment is performed using the area under the ROC curve (AUROC). The value ranges from 0.5 to 1.0. The closer the AUROC value is to one, the higher the prognostic capability of the electroencephalography.

Time frame
Through study completion, an average of 3 year
3

Prognostic value of maximum intraoperative alpha rhythm power for the development of silent brain infarction

The prognostic value assessment is performed using the area under the ROC curve (AUROC). The value ranges from 0.5 to 1.0. The closer the AUROC value is to one, the higher the prognostic capability of the electroencephalography.

Time frame
Through study completion, an average of 3 year
4

The prognostic capability of the "burst suppression" pattern for predicting the development of silent brain infarction

The prognostic value assessment is performed using the area under the ROC curve (AUROC). The value ranges from 0.5 to 1.0. The closer the AUROC value is to one, the higher the prognostic capability of the electroencephalography.

Time frame
Through study completion, an average of 3 year

Other outcomes

1

Serum level of S100 beta protein

Time frame
within 1 hour before surgery, 1 hour after surgery
2

Serum level of Interleukin-6

Time frame
within 1 hour before surgery, 1 hour after surgery

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

City clinical hospital named after SS YudinRecruiting115446, Moscow, Moscow OblastRussiaRussia

Sponsors and contacts

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