SurgeryNCT06545786
Intraoperative Diagnosis of Neurocognitive Complications Via Electroencephalographic Analysis
An observational study of Surgery and Postoperative Delirium, run by Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Postoperative Delirium, Anesthesia
- What is being tested?
- Intraoperative electroencephalography
- Type of treatment
- Medical device
- How many people
- 265 participants
- Where
- 1 siteRussia
- Study dates
- 25 Sep 2024to 20 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for non-cardiac surgery of intermediate to high risk
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
City clinical hospital named after SS Yudin
Moscow, Moscow Oblast, 115446
Valery Likhvantsev, PhD, 89036235982, lik0704@gmail.com
About this study
Official title: Intraoperative Diagnosis of Neurocognitive Complications Via Electroencephalographic (IDEA Network)
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.
Read more
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.
Read the detailed description
Postoperative Neurocognitive Disorders (PND) are one of the most serious and common complications following surgery, especially in elderly patients. Postoperative neurocognitive disorders can impact cognitive functions for a prolonged period post-surgery, sometimes lasting several years. This not only deteriorates the quality of life but also increases hospitalization time and medical costs.
The difficulty in diagnosing postoperative neurocognitive disorders is that postoperative neurocognitive disorders can manifest in various forms, including memory, attention, and executive function problems. The lack of standardized diagnostic criteria and clear biomarkers complicates early identification and prognosis of postoperative neurocognitive disorders.
One of the most studied forms of postoperative neurocognitive disorders is postoperative delirium (POD). Currently, the concept of postoperative delirium development suggests a combination of predisposing and precipitating factors. Furthermore, according to the ICD-10, postoperative delirium is defined as an etiologically nonspecific organic cerebral syndrome characterized by disturbances in consciousness, attention, perception, thinking, memory, psychomotor behavior, emotions, and the sleep-wake cycle. The indication of an organic nature of the lesion prompts researchers to explore the possibility of diagnosing brain dysfunctions clinically manifesting as postoperative delirium.
Electroencephalography (EEG) has long been used in anesthesiology to assess the depth of anesthesia and the risk of awareness during surgery. With the use of modern analysis algorithms, such as spectral analysis and synchronization between different brain regions, electroencephalography opens new horizons for assessing the patient's neurophysiological state. Currently, the use of electroencephalography for monitoring cerebral perfusion and oxygenation is being studied, which is especially critical during cardiothoracic and neurosurgical operations. One study showed that a new interhemispheric similarity index in electroencephalography could serve as an indicator of the risk of complications such as intraoperative stroke and delirium after cardiac surgery. These data demonstrate the possibility of using electroencephalography monitoring as a tool for predicting adverse neurocognitive outcomes.
The relationship between electroencephalography and postoperative delirium has not been sufficiently studied. The hypothesis is that specific electroencephalography patterns may serve as indicators of the organic substrate development of postoperative delirium, which may lead to the study of risk factors and methods of their prevention. This, in turn, will allow anesthesiologists and surgeons to optimize approaches to anesthesia and surgical intervention, minimizing the risk of negative cognitive consequences.
- Conditions
- Surgery, Postoperative Delirium, Anesthesia, Silent Stroke, Emergence Delirium
- Being tested
- Intraoperative electroencephalography
- Keywords
- Non-cardiac surgery, Anesthesia, Postoperative Delirium, Silent Stroke, Emergence Delirium
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative electroencephalographyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-cardiac surgery | Patients scheduled for non-cardiac surgery of intermediate to high risk Receives: Device: Intraoperative electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 3 year
28-days mortality
Number of deaths in period of 28 days after enrollment
Measured: 28 days
1-year mortality
Number of deaths in period of 1 year after enrollment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start25 Sep 2024
- Primary completion20 Aug 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valery Likhvantsev, Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
- Investigators
- Valery Likhvantsev, PhD, Principal investigator, Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545786
- Sponsor's protocol ID
- IDEA Network
- Status last verified
- Nov 2024
- First submitted
- 6 Aug 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Diagnosis of Neurocognitive Complications Via Electroencephalographic (IDEA Network)
- ClinicalTrials.gov ID
- NCT06545786
- Acronym / sponsor ID
- IDEA Network
- Conditions
- Surgery, Postoperative Delirium, Anesthesia, Silent Stroke, Emergence Delirium
- Keywords
- Non-cardiac surgery, Anesthesia, Postoperative Delirium, Silent Stroke, Emergence Delirium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- Federal Research and Clinical Centre of Intensive Care Medicine and RehabilitologyUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 20 Aug 2027 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postoperative Neurocognitive Disorders (PND) are one of the most serious and common complications following surgery, especially in elderly patients. Postoperative neurocognitive disorders can impact cognitive functions for a prolonged period post-surgery, sometimes lasting several years. This not only deteriorates the quality of life but also increases hospitalization time and medical costs.
The difficulty in diagnosing postoperative neurocognitive disorders is that postoperative neurocognitive disorders can manifest in various forms, including memory, attention, and executive function problems. The lack of standardized diagnostic criteria and clear biomarkers complicates early identification and prognosis of postoperative neurocognitive disorders.
One of the most studied forms of postoperative neurocognitive disorders is postoperative delirium (POD). Currently, the concept of postoperative delirium development suggests a combination of predisposing and precipitating factors. Furthermore, according to the ICD-10, postoperative delirium is defined as an etiologically nonspecific organic cerebral syndrome characterized by disturbances in consciousness, attention, perception, thinking, memory, psychomotor behavior, emotions, and the sleep-wake cycle. The indication of an organic nature of the lesion prompts researchers to explore the possibility of diagnosing brain dysfunctions clinically manifesting as postoperative delirium.
Electroencephalography (EEG) has long been used in anesthesiology to assess the depth of anesthesia and the risk of awareness during surgery. With the use of modern analysis algorithms, such as spectral analysis and synchronization between different brain regions, electroencephalography opens new horizons for assessing the patient's neurophysiological state. Currently, the use of electroencephalography for monitoring cerebral perfusion and oxygenation is being studied, which is especially critical during cardiothoracic and neurosurgical operations. One study showed that a new interhemispheric similarity index in electroencephalography could serve as an indicator of the risk of complications such as intraoperative stroke and delirium after cardiac surgery. These data demonstrate the possibility of using electroencephalography monitoring as a tool for predicting adverse neurocognitive outcomes.
The relationship between electroencephalography and postoperative delirium has not been sufficiently studied. The hypothesis is that specific electroencephalography patterns may serve as indicators of the organic substrate development of postoperative delirium, which may lead to the study of risk factors and methods of their prevention. This, in turn, will allow anesthesiologists and surgeons to optimize approaches to anesthesia and surgical intervention, minimizing the risk of negative cognitive consequences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-cardiac surgery | – | Device: Intraoperative electroencephalographyPatients scheduled for non-cardiac surgery of intermediate to high risk |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for non-cardiac surgery of intermediate to high risk
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative electroencephalographyEEG 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. | Device | Non-cardiac surgery |
Primary outcome
Prognostic value of mean intraoperative alpha rhythm power for the development of postoperative delirium
Time frame: Through study completion, an average of 3 year
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.
Prognostic value of mean intraoperative alpha rhythm power for the development of early postoperative neurocognitive disorders
Time frame: Through study completion, an average of 3 year
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.
Prognostic value of mean intraoperative alpha rhythm power for the development of intraoperative silent brain infarction
Time frame: Through study completion, an average of 3 year
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.
10 secondary outcomes
Prognostic value of maximum intraoperative alpha rhythm power for the development of postoperative delirium
Time frame: Through study completion, an average of 3 year
Prognostic value of maximum intraoperative alpha rhythm power for the development of early postoperative neurocognitive disorders
Time frame: Through study completion, an average of 3 year
Prognostic value of maximum intraoperative alpha rhythm power for the development of silent brain infarction
Time frame: Through study completion, an average of 3 year
The prognostic capability of the "burst suppression" pattern for predicting the development of silent brain infarction
Time frame: Through study completion, an average of 3 year
The prognostic capability of the "burst suppression" pattern for predicting the development of postoperative delirium.
Time frame: 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.
Time frame: Through study completion, an average of 3 year
The prognostic value of early postoperative neurocognitive disorders for predicting the development of postoperative delirium.
Time frame: Through study completion, an average of 3 year
The prognostic value of postoperative delirium for predicting the development of silent brain infarction
Time frame: Through study completion, an average of 3 year
28-days mortality
Time frame: 28 days
1-year mortality
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valery Likhvantsev, PhD principal investigator
Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Postoperative Delirium, run by Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valery Likhvantsev, PhD (89036235982, lik0704@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic value of mean intraoperative alpha rhythm power for the development of postoperative delirium (time frame: Through study completion, an average of 3 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.