Intraoperative Diagnosis of Neurocognitive Complications Via Electroencephalographic Analysis

NCT06545786 | Recruiting DMC

• 1 other identifier: IDEA Network
• Study Type: observational
• Target: 265
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery; Postoperative Delirium; Anesthesia; Silent Stroke; Emergence Delirium

Keywords

Non-cardiac surgery; Anesthesia; Postoperative Delirium; Silent Stroke; Emergence Delirium

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

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

  Through study completion, an average of 3 year

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

  Through study completion, an average of 3 year

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

  Through study completion, an average of 3 year

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

  Through study completion, an average of 3 year

• The prognostic capability of the "burst suppression" pattern for predicting the development of postoperative delirium.

  Through study completion, an average of 3 year

Other Outcomes (2)

• Serum level of S100 beta protein

  within 1 hour before surgery, 1 hour after surgery

• Serum level of Interleukin-6

  within 1 hour before surgery, 1 hour after surgery

Study Arms (1)

Non-cardiac surgery

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

Device: Intraoperative electroencephalography

Interventions

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.

Non-cardiac surgery

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 scheduled for non-cardiac surgery of intermediate to high risk

You may qualify if:

• 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

You may not qualify if:

• Preoperative MMSE score less than 20 points
• History of any mental illness
• Presence of neuromuscular diseases
• Neurosurgical procedures
• Inability to undergo preoperative testing for any reason

Sponsors & Collaborators

• Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology: lead

Study Sites (1)

City clinical hospital named after SS Yudin

Moscow, Moscow Oblast, 115446, Russia

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Valery Likhvantsev, PhD

  Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valery Likhvantsev, PhD

CONTACT

89036235982; lik0704@gmail.com

Levan Berikashvili, PhD

CONTACT

89263308968; levan.berikashvili@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: September 25, 2024
• Primary Completion (Estimated): August 20, 2027
• Study Completion (Estimated): August 20, 2027
• Last Updated: April 8, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)