NCT06545786 Intraoperative Diagnosis of Neurocognitive Complications Via Electroencephalographic Analysis
| NCT ID | NCT06545786 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology |
| Condition | Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 265 participants |
| Start Date | 2024-09-25 |
| Primary Completion | 2027-08-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 265 participants in total. It began in 2024-09-25 with a primary completion date of 2027-08-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Neurosurgical procedures * Inability to undergo preoperative testing for any reason
Contact & Investigator
Valery Likhvantsev, PhD
PRINCIPAL INVESTIGATOR
Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
Frequently Asked Questions
Who can join the NCT06545786 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06545786 currently recruiting?
Yes, NCT06545786 is actively recruiting participants. Contact the research team at lik0704@gmail.com for enrollment information.
Where is the NCT06545786 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT06545786 clinical trial?
NCT06545786 is sponsored by Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology. The principal investigator is Valery Likhvantsev, PhD at Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology. The trial plans to enroll 265 participants.