Intraoperative Diagnosis of Neurocognitive Complications Via Electroencephalographic Analysis
NCT Number: NCT06545786
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Surgery|Postoperative Delirium|Anesthesia|Silent Stroke|Emergence Delirium
Interventions: DEVICE: Intraoperative electroencephalography
Sponsor: Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 265
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-20
Completion Date: 2027-08-20
Locations: City clinical hospital named after SS Yudin, Moscow, Moscow Region, 115446, Russian Federation

Summary:
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.

Primary Outcome Measures: 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., Through study completion, an average of 3 year|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., Through study completion, an average of 3 year|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., Through study completion, an average of 3 year
Secondary Outcome Measures: 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., Through study completion, an average of 3 year|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., Through study completion, an average of 3 year|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., Through study completion, an average of 3 year|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., Through study completion, an average of 3 year|The prognostic capability of the "burst suppression" pattern for predicting 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., Through study completion, an average of 3 year|The prognostic capability of the "burst suppression" pattern for predicting 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., Through study completion, an average of 3 year|The prognostic value of early postoperative neurocognitive disorders for predicting 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., Through study completion, an average of 3 year|The prognostic value of postoperative delirium 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., Through study completion, an average of 3 year|28-days mortality, Number of deaths in period of 28 days after enrollment, 28 days|1-year mortality, Number of deaths in period of 1 year after enrollment, 1 year