Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:13 AM
Study NCT ID:
NCT07388160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-04
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuroinflammatory Biomarkers After General Anesthesia: A Comparison Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-09-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-30', 'studyFirstSubmitDate': '2026-01-23', 'studyFirstSubmitQcDate': '2026-01-30', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Serum BDNF Levels', 'timeFrame': 'Preoperative (baseline) and 24 hours postoperative', 'description': 'Change in serum Brain-Derived Neurotrophic Factor (BDNF) concentration measured by ELISA method, comparing preoperative baseline levels with postoperative levels at 24 hours'}, {'measure': 'Change in Serum HMGB1 Levels', 'timeFrame': 'Preoperative (baseline) and 24 hours postoperative', 'description': 'Change in serum High Mobility Group Box 1 (HMGB1) concentration measured by ELISA method, comparing preoperative baseline levels with postoperative levels at 24 hours'}, {'measure': 'Change in Serum IL-1β Levels', 'timeFrame': 'Preoperative (baseline) and 24 hours postoperative', 'description': 'Change in serum Interleukin-1 beta (IL-1β) concentration measured by ELISA method, comparing preoperative baseline levels with postoperative levels at 24 hours'}], 'secondaryOutcomes': [{'measure': 'Correlation Between Biomarkers', 'timeFrame': 'At 24 hours postoperative', 'description': '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'}, {'measure': 'Comparison Between Single vs Multiple Anesthesia Exposure Groups', 'timeFrame': 'Preoperative (baseline) and 24 hours postoperative', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Brain Derived Neurotrophic Factor', 'Interleukin-1 beta', 'General Anesthesia', 'Neuroinflammation', 'Cognitive Dysfunction', 'Biomarkers', 'Sevofluran', 'Inflammatory Cytokines', 'Anesthesia Neurotoxicity'], 'conditions': ['Anesthesia', 'Neuroinflammation', 'Cognitive Disorders']}, 'descriptionModule': {'briefSummary': '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).\n\nSerum 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-65 years\n* Scheduled for elective cholecystectomy surgery\n* Either no previous general anesthesia exposure OR at least one or more previous general anesthesia exposures\n* Ability to provide informed consent\n* American Society of Anesthesiologists (ASA) physical status I-II\n\nExclusion Criteria:\n\n* Chronic neurological diseases (Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc.)\n* Psychiatric illness requiring medication\n* Metabolic syndrome (diabetes mellitus, hypertension, cardiac disease)\n* Chronic inflammatory diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)\n* Corticosteroid or immunosuppressive therapy within the last 6 months\n* Patients requiring intensive care admission\n* Pregnancy or breastfeeding\n* Known allergy to anesthetic agents\n* Inability to provide informed consent"}, 'identificationModule': {'nctId': 'NCT07388160', 'briefTitle': 'Neuroinflammatory Biomarkers After General Anesthesia: A Comparison Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University of Health Sciences Balikesir Hospital Eduation and Research'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 's.kutlusoy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No Previous General Anesthesia', 'description': '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.'}, {'label': 'Previous General Anesthesia Exposure', 'description': '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.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'sevgi kutlusoy, Assoc. Prof. Dr.', 'role': 'CONTACT', 'email': 'stopal70@hotmail.com', 'phone': '+905449696144'}], 'overallOfficials': [{'name': 'sevgi kutlusoy, Assoc. Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Saglik Bilimleri Universitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Health Sciences Balikesir Hospital Eduation and Research', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Malatya Turgut Ozal University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}