Neuroinflammatory Biomarkers After General Anesthesia: A Comparison Study

NCT07388160 | Not Yet Recruiting

• 1 other identifier: s.kutlusoy
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anesthesia; Neuroinflammation; Cognitive Disorders

Keywords

Brain Derived Neurotrophic Factor; Interleukin-1 beta; General Anesthesia; Neuroinflammation; Cognitive Dysfunction; Biomarkers; Sevofluran; Inflammatory Cytokines; Anesthesia Neurotoxicity

Outcome Measures

Primary Outcomes (3)

• 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

  Preoperative (baseline) and 24 hours postoperative

• 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

  Preoperative (baseline) and 24 hours postoperative

• 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

  Preoperative (baseline) and 24 hours postoperative

Secondary Outcomes (2)

• Correlation Between Biomarkers

  At 24 hours postoperative

• Comparison Between Single vs Multiple Anesthesia Exposure Groups

  Preoperative (baseline) and 24 hours postoperative

Study Arms (2)

No Previous General Anesthesia

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

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Malatya Turgut Ozal University: collaborator
• University of Health Sciences Balikesir Hospital Eduation and Research: lead

MeSH Terms

Conditions

Neuroinflammatory Diseases; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• sevgi kutlusoy, Assoc. Prof. Dr.

  Saglik Bilimleri Universitesi

  STUDY CHAIR

Central Study Contacts

sevgi kutlusoy, Assoc. Prof. Dr.

CONTACT

+905449696144; stopal70@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 4, 2026
• Study Start: January 25, 2026
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01