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Not yet recruiting NCT07388160

Neuroinflammatory Biomarkers After General Anesthesia: A Comparison Study

Observational Anesthesia Neuroinflammation Cognitive Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Anesthesia, Neuroinflammation, Cognitive Disorders. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Primary outcome measures

  • Change in Serum BDNF Levels [Time frame: Preoperative (baseline) and 24 hours postoperative]
  • Change in Serum HMGB1 Levels [Time frame: Preoperative (baseline) and 24 hours postoperative]
  • Change in Serum IL-1β Levels [Time frame: Preoperative (baseline) and 24 hours postoperative]
Secondary outcome measures (2)
  • Correlation Between Biomarkers [Time frame: At 24 hours postoperative]
  • Comparison Between Single vs Multiple Anesthesia Exposure Groups [Time frame: Preoperative (baseline) and 24 hours postoperative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07388160 · s.kutlusoy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗