About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial population
This study will enroll adult patients aged 18-65 years scheduled for elective cholecystectomy surgery at Malatya Turgut Özal University Training and Research Hospital. Participants will be divided into two groups based on their previous general anesthesia exposure history: (1) patients with no prior general anesthesia exposure (control group, n=80), and (2) patients with at least one or more previous general anesthesia exposures (study group, n=80). Healthy volunteers with no previous surgical or anesthesia history will comprise the control group, while patients with previous surgical procedures requiring general anesthesia will comprise the study group. Both groups will be matched for age and body mass index. Participants with chronic neurological diseases, psychiatric disorders, metabolic syndrome, chronic inflammatory conditions, or recent immunosuppressive therapy will be excluded.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in Serum BDNF Levels
Change in serum Brain-Derived Neurotrophic Factor (BDNF) concentration measured by ELISA method, comparing preoperative baseline levels with postoperative levels at 24 hours
Change in Serum HMGB1 Levels
Change in serum High Mobility Group Box 1 (HMGB1) concentration measured by ELISA method, comparing preoperative baseline levels with postoperative levels at 24 hours
Change in Serum IL-1β Levels
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
Correlation Between Biomarkers
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
Comparison Between Single vs Multiple Anesthesia Exposure Groups
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)
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Health Sciences Balikesir Hospital Eduation and Research
Lead sponsor
Malatya Turgut Ozal University
Collaborator
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