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NCT Number: NCT07388160

Neuroinflammatory Biomarkers After General Anesthesia: A Comparison Study

This prospective, observational study investigates the impact of repeated general anesthesia exposure on neuroinflammatory biomarkers and neurotrophic factors. The study will enroll 160 adult patients (aged 18-65 years) scheduled for elective cholecystectomy surgery, divided into two groups: patients with no previous general anesthesia exposure (n=80) and patients with at least one or more previous general anesthesia exposures (n=80).

Serum levels of Brain-Derived Neurotrophic Factor (BDNF), Interleukin-1 beta (IL-1β), and High Mobility Group Box 1 (HMGB1) will be measured using ELISA method at two time points: preoperatively (baseline) and 24 hours postoperatively. Cognitive function will also be assessed at both time points.

The primary objective is to evaluate whether multiple exposures to general anesthesia lead to significant differences in serum BDNF, IL-1β, and HMGB1 levels, reflecting changes in neurotrophic balance and neuroinflammatory response. This study aims to provide insights into the potential biochemical mechanisms underlying anesthesia-related cognitive changes and contribute original clinical data to the current literature on general anesthesia safety and neurobiological effects.

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Key information

Conditions

Anesthesia Cognition Disorders Cognitive Disorders Cognitive Dysfunction Inflammation Mental Disorders Nervous System Diseases Neurocognitive Disorders Neuroinflammation Neuroinflammatory Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18-65 years
  • Scheduled for elective cholecystectomy surgery
  • Either no previous general anesthesia exposure OR at least one or more previous general anesthesia exposures
  • Ability to provide informed consent
  • American Society of Anesthesiologists (ASA) physical status I-II

Exclusion criteria

  • Chronic neurological diseases (Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc.)
  • Psychiatric illness requiring medication
  • Metabolic syndrome (diabetes mellitus, hypertension, cardiac disease)
  • Chronic inflammatory diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
  • Corticosteroid or immunosuppressive therapy within the last 6 months
  • Patients requiring intensive care admission
  • Pregnancy or breastfeeding
  • Known allergy to anesthetic agents
  • Inability to provide informed consent

Treatment and study plan

Primary outcomes

  1. Change in Serum BDNF Levels

    Time frame: Preoperative (baseline) and 24 hours postoperative

    Change in serum Brain-Derived Neurotrophic Factor (BDNF) concentration measured by ELISA method, comparing preoperative baseline levels with postoperative levels at 24 hours

  2. Change in Serum HMGB1 Levels

    Time frame: Preoperative (baseline) and 24 hours postoperative

    Change in serum High Mobility Group Box 1 (HMGB1) concentration measured by ELISA method, comparing preoperative baseline levels with postoperative levels at 24 hours

  3. Change in Serum IL-1β Levels

    Time frame: Preoperative (baseline) and 24 hours postoperative

    Change in serum Interleukin-1 beta (IL-1β) concentration measured by ELISA method, comparing preoperative baseline levels with postoperative levels at 24 hours

Secondary outcomes

  1. Correlation Between Biomarkers

    Time frame: At 24 hours postoperative

    Analysis of correlations between serum BDNF, IL-1β, and HMGB1 levels to evaluate the relationship between neurotrophic balance and systemic inflammatory response following general anesthesia

  2. Comparison Between Single vs Multiple Anesthesia Exposure Groups

    Time frame: Preoperative (baseline) and 24 hours postoperative

    Statistical comparison of serum BDNF, IL-1β, and HMGB1 levels between patients with no previous general anesthesia exposure and those with previous general anesthesia exposure(s)

Study contacts

Contact information is provided by the study sponsor or research team.

sevgi kutlusoy, Assoc. Prof. Dr.

CONTACT

[email protected]

+905449696144

Sponsors and collaborators

Lead sponsor

University of Health Sciences Balikesir Hospital Eduation and Research

Other Gov

Collaborators

  • Malatya Turgut Ozal University

Registry information

Official study title

Evaluation of Preoperative and Postoperative Serum BDNF, IL-1β, and HMGB1 Levels and Cognitive Changes in Patients Undergoing General Anesthesia: Differences Between Patients With No Prior General Anesthesia and Those With Multiple Anesthesia Exposures

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2026
Registry last updated
Feb 4, 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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