- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07509372
Evaluation of the Predictive Impact of Serum S100B and S100B Polymorphisms on Postoperative Cognitive Dysfunction and Delirium
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Ankara
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Ankara, Ankara, Turkey (Türkiye), 06000
- Ankara University Faculty of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Cognitive Dysfunction
Time Frame: 6 months after surgery
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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.
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6 months after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Delirium
Time Frame: Within the first 3 postoperative days
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Incidence of postoperative delirium assessed during the first 3 postoperative days.
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Within the first 3 postoperative days
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Perioperative Serum S100B Levels
Time Frame: Preoperatively and within 30 minutes after surgery
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Serum S100B protein levels measured in blood samples collected preoperatively and within 30 minutes after surgery.
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Preoperatively and within 30 minutes after surgery
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S100B Gene Polymorphisms
Time Frame: Preoperative period
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Single nucleotide polymorphisms in the S100B gene analyzed from preoperative blood samples.
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Preoperative period
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Nasreddine 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.
- Ayob 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Postoperative Complications
- Pathologic Processes
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Inflammation
- Cognition Disorders
- Delirium
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Postoperative Cognitive Complications
- Emergence Delirium
- Neuroinflammatory Diseases
- Cognitive Dysfunction
Other Study ID Numbers
- AU-ANES-MB-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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