Neuroinflammatory Biomarkers After General Anesthesia: A Comparison Study

January 30, 2026 updated by: University of Health Sciences Balikesir Hospital Eduation and Research

Evaluation of Preoperative and Postoperative Serum BDNF, IL-1β, and HMGB1 Levels and Cognitive Changes in Patients Undergoing General Anesthesia: Differences Between Patients With No Prior General Anesthesia and Those With Multiple Anesthesia Exposures

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum BDNF Levels
Time Frame: Preoperative (baseline) and 24 hours postoperative
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
Time Frame: Preoperative (baseline) and 24 hours postoperative
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
Time Frame: Preoperative (baseline) and 24 hours postoperative
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between Biomarkers
Time Frame: At 24 hours postoperative
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
At 24 hours postoperative
Comparison Between Single vs Multiple Anesthesia Exposure Groups
Time Frame: Preoperative (baseline) and 24 hours postoperative
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)
Preoperative (baseline) and 24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Health Sciences Balikesir Hospital Eduation and Research

Collaborators

Malatya Turgut Ozal University

Investigators

  • Study Chair: sevgi kutlusoy, Assoc. Prof. Dr., Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 25, 2026

Primary Completion (Estimated)

August 25, 2026

Study Completion (Estimated)

September 25, 2026

Study Registration Dates

First Submitted

January 23, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s.kutlusoy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The decision to share individual participant data (IPD) will be made after consultation with the institutional ethics committee and upon completion of primary analyses. Any data sharing will be contingent upon appropriate ethical approval, participant consent provisions, and establishment of a formal data sharing agreement. The final decision will be determined based on ethical, legal, and privacy considerations specific to the Turkish healthcare system and institutional policies.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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