AnesthesiaNCT07388160
Neuroinflammatory Biomarkers After General Anesthesia: A Comparison Study
An observational study of Anesthesia and Neuroinflammation, run by University of Health Sciences Balikesir Hospital Eduation and Research.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Neuroinflammation, Cognitive Disorders
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2026to 25 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- Pregnancy or breastfeeding
- Known allergy to anesthetic agents
- Inability to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Anesthesia, Neuroinflammation, Cognitive Disorders
- Keywords
- Brain Derived Neurotrophic Factor, Interleukin-1 beta, General Anesthesia, Neuroinflammation, Cognitive Dysfunction, Biomarkers, Sevofluran, Inflammatory Cytokines, Anesthesia Neurotoxicity
- Medical subject headings
- Neuroinflammatory Diseases, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Preoperative (baseline) and 24 hours postoperative
Secondary outcomes (2)
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
Measured: At 24 hours postoperative
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)
Measured: Preoperative (baseline) and 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start25 Jan 2026 (estimated)
- Primary completion25 Aug 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Balikesir Hospital Eduation and Research
- Sponsor type
- Other government
- Collaborators
- Malatya Turgut Ozal University
- Responsible party
- Sponsor
- Investigators
- sevgi kutlusoy, Assoc. Prof. Dr., Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388160
- Sponsor's protocol ID
- s.kutlusoy
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07388160
- Acronym / sponsor ID
- s.kutlusoy
- Conditions
- Anesthesia, Neuroinflammation, Cognitive Disorders
- Keywords
- Brain Derived Neurotrophic Factor, Interleukin-1 beta, General Anesthesia, Neuroinflammation, Cognitive Dysfunction, Biomarkers, Sevofluran, Inflammatory Cytokines
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of Health Sciences Balikesir Hospital Eduation and ResearchOther government
- Collaborators
- Malatya Turgut Ozal University
- Study start
- 25 Jan 2026 (estimated)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
2 secondary outcomes
Correlation Between Biomarkers
Time frame: At 24 hours postoperative
Comparison Between Single vs Multiple Anesthesia Exposure Groups
Time frame: Preoperative (baseline) and 24 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
sevgi kutlusoy, Assoc. Prof. Dr. study chair
Saglik Bilimleri Universitesi
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Neuroinflammation, run by University of Health Sciences Balikesir Hospital Eduation and Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact sevgi kutlusoy, Assoc. Prof. Dr. (+905449696144, stopal70@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum BDNF Levels (time frame: Preoperative (baseline) and 24 hours postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.