Neuroinflammatory Biomarkers After General Anesthesia: A Comparison Study (NCT07388160) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Neuroinflammatory Biomarkers After General Anesthesia: A Comparison Study
160 participantsStarted 2026-01-25
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Serum BDNF Levels
Timeframe: Preoperative (baseline) and 24 hours postoperative
2
Change in Serum HMGB1 Levels
Timeframe: Preoperative (baseline) and 24 hours postoperative
3
Change in Serum IL-1β Levels
Timeframe: Preoperative (baseline) and 24 hours postoperative
Trial details
NCT IDNCT07388160
SponsorUniversity of Health Sciences Balikesir Hospital Eduation and Research