Neuroinflammatory Biomarkers After General Anesthesia: A Comparison Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Health Sciences Balikesir Hospital Eduation and Research

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

160 Participants
are grouped into 2 trial groups
Group A: No Previous General Anesthesia
Group B: Previous General Anesthesia Exposure

Trial outcomes

Primary outcomes

1

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

Time frame
Preoperative (baseline) and 24 hours postoperative
2

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

Time frame
Preoperative (baseline) and 24 hours postoperative
3

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

Time frame
Preoperative (baseline) and 24 hours postoperative

Secondary outcomes

1

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

Time frame
At 24 hours postoperative
2

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)

Time frame
Preoperative (baseline) and 24 hours postoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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