Postoperative Cognitive DysfunctionNCT07509372
Evaluation of the Predictive Impact of Serum S100B and S100B Polymorphisms on Postoperative Cognitive Dysfunction and Delirium
An observational study of Postoperative Cognitive Dysfunction and Delirium, Postoperative, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative cognitive disorders, including postoperative cognitive dysfunction (POCD) and postoperative delirium (POD), are common complications following surgery and anesthesia, particularly in vulnerable patient populations. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Delirium, Postoperative
- What is being tested?
- Perioperative Assessment
- How many people
- 137 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Sep 2023to 6 Nov 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients undergoing elective surgery under anesthesia who were prospectively enrolled. Patients were evaluated for postoperative cognitive dysfunction and postoperative delirium using standardized cognitive assessments. Perioperative blood samples were collected for the measurement of serum S100B levels and for the analysis of S100B gene polymorphisms. All participants were followed for cognitive outcomes up to 6 months after surgery.
Who may be able to join
- Adult patients (≥18 years) undergoing elective surgery under anesthesia
- Patients able to provide informed consent
- Patients with sufficient cognitive function to complete cognitive assessments
- Patients who agreed to participate in follow-up evaluations
Who cannot join
- Patients with a history of neurological or psychiatric disorders affecting cognitive function
- Patients with diagnosed dementia or severe cognitive impairment
- Patients with inability to complete cognitive tests (e.g., severe visual, hearing, or language impairment)
- Patients with alcohol or substance abuse
- Patients undergoing emergency surgery
- Patients with missing baseline cognitive assessment
- Patients who refused participation or were lost to follow-up
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Medicine
Ankara, Ankara, 06000
About this study
Official title: Investigation of the Predictive Effect of Serum S100B and S100B Polymorphisms on Postoperative Cognitive Dysfunction and Delirium in Patients Undergoing Surgery With Bispectral Index Monitoring
Postoperative cognitive disorders, including postoperative cognitive dysfunction (POCD) and postoperative delirium (POD), are common complications following surgery and anesthesia, particularly in vulnerable patient populations. These conditions are associated with increased morbidity, prolonged hospitalization, and higher healthcare costs. Early identification of patients at risk remains challenging, and reliable biomarkers are needed to improve perioperative risk stratification.
S100B protein has been proposed as a biomarker of neuronal injury and blood-brain barrier dysfunction. In addition, genetic variations in the S100B gene may influence individual susceptibility to postoperative cognitive impairment.
The aim of this prospective cohort study is to evaluate the association between perioperative serum S100B levels, S100B gene polymorphisms, and postoperative cognitive disorders. Furthermore, the predictive value of perioperative changes in S100B levels for postoperative cognitive dysfunction and delirium will be investigated.
Read the detailed description
Postoperative cognitive disorders, including postoperative cognitive dysfunction (POCD) and postoperative delirium (POD), are common complications associated with surgery and anesthesia. These conditions affect perception, memory, and learning abilities, and are associated with increased morbidity, prolonged hospital and intensive care unit stays, and higher healthcare costs. Although the exact mechanisms underlying these disorders are not fully understood, perioperative inflammatory processes and neuronal injury are considered key contributing factors.
In recent years, considerable research has focused on identifying reliable biomarkers for the early prediction of postoperative cognitive disorders. Among these, S100B protein has emerged as a promising marker of neuronal injury and blood-brain barrier dysfunction. In addition, single nucleotide polymorphisms (SNPs) in the S100B gene may influence individual susceptibility to cognitive impairment.
The aim of this study is to investigate the relationship between serum S100B levels, S100B gene polymorphisms, and postoperative cognitive disorders.
In this prospective study, preoperative cognitive function will be assessed using standardized cognitive tests. Blood samples will be collected preoperatively and within 30 minutes after surgery for the measurement of serum S100B levels. Cognitive assessment will be performed preoperatively and repeated at 1, 3, and 6 months after surgery. Patients will also be evaluated for postoperative delirium during the first 3 postoperative days.
The incidence of postoperative cognitive dysfunction and postoperative delirium will be recorded, and the association between S100B levels, genetic polymorphisms, and cognitive outcomes will be analyzed. The predictive value of these biomarkers for postoperative cognitive disorders will also be evaluated. Particular emphasis will be placed on the perioperative change in S100B levels (ΔS100B) as a potential predictor of postoperative cognitive outcomes.
- Being tested
- Perioperative Assessment
- Keywords
- human S100 beta protein, Postoperative Cognitive Dysfunction, Postoperative Delirium, Cognitive Impairment, Neuroinflammation, Anesthesia, Biomarker
- Medical subject headings
- Postoperative Cognitive Complications, Emergence Delirium, Cognitive Dysfunction, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative AssessmentOther
Observational study with no assigned intervention. Patients were evaluated with perioperative blood sampling for S100B levels and genetic analysis, and were followed for postoperative cognitive outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Patients | Patients undergoing surgery who were prospectively followed for postoperative delirium and postoperative cognitive dysfunction with serial cognitive assessments, serum S100B measurements, and S100B gene polymorphism analyses. Receives: Other: Perioperative Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Cognitive Dysfunction
Postoperative cognitive dysfunction assessed using the Montreal Cognitive Assessment (MoCA). Cognitive assessment was performed preoperatively and repeated at 1, 3, and 6 months after surgery.
Measured: 6 months after surgery
Secondary outcomes (3)
Postoperative Delirium
Incidence of postoperative delirium assessed during the first 3 postoperative days.
Measured: Within the first 3 postoperative days
Perioperative Serum S100B Levels
Serum S100B protein levels measured in blood samples collected preoperatively and within 30 minutes after surgery.
Measured: Preoperatively and within 30 minutes after surgery
S100B Gene Polymorphisms
Single nucleotide polymorphisms in the S100B gene analyzed from preoperative blood samples.
Measured: Preoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start27 Sep 2023
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- 137 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sait Bilgic, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509372
- Sponsor's protocol ID
- AU-ANES-MB-01
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the Nomenclature of Cognitive Change Associated with Anaesthesia and Surgery-2018. Anesthesiology. 2018 Nov;129(5):872-879. doi: 10.1097/ALN.0000000000002334.
PubMed 30325806Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019Ayob F, Lam E, Ho G, Chung F, El-Beheiry H, Wong J. Pre-operative biomarkers and imaging tests as predictors of post-operative delirium in non-cardiac surgical patients: a systematic review. BMC Anesthesiol. 2019 Feb 23;19(1):25. doi: 10.1186/s12871-019-0693-y.
PubMed 30797230
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Predictive Effect of Serum S100B and S100B Polymorphisms on Postoperative Cognitive Dysfunction and Delirium in Patients Undergoing Surgery With Bispectral Index Monitoring
- ClinicalTrials.gov ID
- NCT07509372
- Acronym / sponsor ID
- AU-ANES-MB-01
- Keywords
- human S100 beta protein, Postoperative Cognitive Dysfunction, Postoperative Delirium, Cognitive Impairment, Neuroinflammation, Anesthesia, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 3 Apr 2026 (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 cognitive disorders, including postoperative cognitive dysfunction (POCD) and postoperative delirium (POD), are common complications following surgery and anesthesia, particularly in vulnerable patient populations. These conditions are associated with increased morbidity, prolonged hospitalization, and higher healthcare costs. Early identification of patients at risk remains challenging, and reliable biomarkers are needed to improve perioperative risk stratification.
S100B protein has been proposed as a biomarker of neuronal injury and blood-brain barrier dysfunction. In addition, genetic variations in the S100B gene may influence individual susceptibility to postoperative cognitive impairment.
The aim of this prospective cohort study is to evaluate the association between perioperative serum S100B levels, S100B gene polymorphisms, and postoperative cognitive disorders. Furthermore, the predictive value of perioperative changes in S100B levels for postoperative cognitive dysfunction and delirium will be investigated.
Detailed description
Postoperative cognitive disorders, including postoperative cognitive dysfunction (POCD) and postoperative delirium (POD), are common complications associated with surgery and anesthesia. These conditions affect perception, memory, and learning abilities, and are associated with increased morbidity, prolonged hospital and intensive care unit stays, and higher healthcare costs. Although the exact mechanisms underlying these disorders are not fully understood, perioperative inflammatory processes and neuronal injury are considered key contributing factors.
In recent years, considerable research has focused on identifying reliable biomarkers for the early prediction of postoperative cognitive disorders. Among these, S100B protein has emerged as a promising marker of neuronal injury and blood-brain barrier dysfunction. In addition, single nucleotide polymorphisms (SNPs) in the S100B gene may influence individual susceptibility to cognitive impairment.
The aim of this study is to investigate the relationship between serum S100B levels, S100B gene polymorphisms, and postoperative cognitive disorders.
In this prospective study, preoperative cognitive function will be assessed using standardized cognitive tests. Blood samples will be collected preoperatively and within 30 minutes after surgery for the measurement of serum S100B levels. Cognitive assessment will be performed preoperatively and repeated at 1, 3, and 6 months after surgery. Patients will also be evaluated for postoperative delirium during the first 3 postoperative days.
The incidence of postoperative cognitive dysfunction and postoperative delirium will be recorded, and the association between S100B levels, genetic polymorphisms, and cognitive outcomes will be analyzed. The predictive value of these biomarkers for postoperative cognitive disorders will also be evaluated. Particular emphasis will be placed on the perioperative change in S100B levels (ΔS100B) as a potential predictor of postoperative cognitive outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Patients | – | Other: Perioperative AssessmentPatients undergoing surgery who were prospectively followed for postoperative delirium and postoperative cognitive dysfunction with serial cognitive assessments, serum S100B measurements, and S100B gene polymorphism analyses. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients undergoing elective surgery under anesthesia who were prospectively enrolled. Patients were evaluated for postoperative cognitive dysfunction and postoperative delirium using standardized cognitive assessments. Perioperative blood samples were collected for the measurement of serum S100B levels and for the analysis of S100B gene polymorphisms. All participants were followed for cognitive outcomes up to 6 months after surgery.
Key inclusion criteria (4 listed)
- Adult patients (≥18 years) undergoing elective surgery under anesthesia
- Patients able to provide informed consent
- Patients with sufficient cognitive function to complete cognitive assessments
- Patients who agreed to participate in follow-up evaluations
Key exclusion criteria (7 listed)
- Patients with a history of neurological or psychiatric disorders affecting cognitive function
- Patients with diagnosed dementia or severe cognitive impairment
- Patients with inability to complete cognitive tests (e.g., severe visual, hearing, or language impairment)
- Patients with alcohol or substance abuse
- Patients undergoing emergency surgery
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 |
|---|---|---|
| Perioperative AssessmentObservational study with no assigned intervention. Patients were evaluated with perioperative blood sampling for S100B levels and genetic analysis, and were followed for postoperative cognitive outcomes. | Other | Surgical Patients |
Primary outcome
Postoperative Cognitive Dysfunction
Time frame: 6 months after surgery
Postoperative cognitive dysfunction assessed using the Montreal Cognitive Assessment (MoCA). Cognitive assessment was performed preoperatively and repeated at 1, 3, and 6 months after surgery.
3 secondary outcomes
Postoperative Delirium
Time frame: Within the first 3 postoperative days
Perioperative Serum S100B Levels
Time frame: Preoperatively and within 30 minutes after surgery
S100B Gene Polymorphisms
Time frame: Preoperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: PubMed 30325806Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the Nomenclature of Cognitive Change Associated with Anaesthesia and Surgery-2018. Anesthesiology. 2018 Nov;129(5):872-879. doi: 10.1097/ALN.0000000000002334.
- Background: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- Background: PubMed 30797230Ayob F, Lam E, Ho G, Chung F, El-Beheiry H, Wong J. Pre-operative biomarkers and imaging tests as predictors of post-operative delirium in non-cardiac surgical patients: a systematic review. BMC Anesthesiol. 2019 Feb 23;19(1):25. doi: 10.1186/s12871-019-0693-y.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Postoperative Cognitive Dysfunction and Delirium, Postoperative, run by Ankara University at 1 site in Turkey (Türkiye).
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 7 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: finished, as of the sponsor's last update on 3 Apr 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Cognitive Dysfunction (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07509372, which also lists 3 linked publications.
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 3 Apr 2026.