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Neuroinflammatory Biomarkers After General Anesthesia: A Comparison Study

U

University of Health Sciences Balikesir Hospital Eduation and Research

Status

Not yet enrolling

Conditions

Cognitive Disorders
Neuroinflammation
Anesthesia

Study type

Observational

Funder types

Other

Identifiers

NCT07388160
s.kutlusoy

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

160 participants in 2 patient groups

No Previous General Anesthesia
Description:
Healthy volunteers aged 18-65 years who have never undergone general anesthesia. This control group will undergo elective cholecystectomy surgery under general anesthesia. Blood samples will be collected preoperatively and 24 hours postoperatively to measure serum BDNF, IL-1β, and HMGB1 levels. Cognitive function will also be assessed at both time points.
Previous General Anesthesia Exposure
Description:
Patients aged 18-65 years scheduled for elective cholecystectomy who have received general anesthesia at least once or multiple times in the past. Blood samples will be collected preoperatively and 24 hours postoperatively to measure serum BDNF, IL-1β, and HMGB1 levels. Cognitive function will also be assessed at both time points. This group will be compared with the control group to evaluate the impact of repeated anesthesia exposure on neuroinflammatory biomarkers and neurotrophic balance.

Trial contacts and locations

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Central trial contact

sevgi kutlusoy, Assoc. Prof. Dr.

Data sourced from clinicaltrials.gov

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