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NCT Number: NCT07509372

Evaluation of the Predictive Impact of Serum S100B and S100B Polymorphisms on Postoperative Cognitive Dysfunction and Delirium

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perioperative Assessment

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative Delirium

    Time frame: Within the first 3 postoperative days

    Incidence of postoperative delirium assessed during the first 3 postoperative days.

  2. Perioperative Serum S100B Levels

    Time frame: Preoperatively and within 30 minutes after surgery

    Serum S100B protein levels measured in blood samples collected preoperatively and within 30 minutes after surgery.

  3. S100B Gene Polymorphisms

    Time frame: Preoperative period

    Single nucleotide polymorphisms in the S100B gene analyzed from preoperative blood samples.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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