Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT07214558
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2025-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spinal Versus General Anesthesia and Inflammatory Response Measured by Delta Neutrophil Index in Total Knee Arthroplasty: An Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-09-22', 'studyFirstSubmitQcDate': '2025-10-02', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Delta Neutrophil Index (DNI)', 'timeFrame': 'From baseline (preoperative) to 24 hours postoperative.', 'description': 'Difference in DNI values measured preoperatively and postoperatively in patients undergoing total knee arthroplasty under spinal versus general anesthesia.'}], 'secondaryOutcomes': [{'measure': 'Neutrophil Count', 'timeFrame': 'Preoperative to 24 hours postoperative.', 'description': 'Absolute neutrophil count measured preoperatively and at 24 hours postoperatively.'}, {'measure': 'Perioperative Complications', 'timeFrame': 'Intraoperative and during hospital stay (up to 7 days).', 'description': 'Incidence of complications such as infection, bleeding, or cardiovascular events.'}, {'measure': 'Operative Time', 'timeFrame': 'Intraoperative period.', 'description': 'Duration of surgery recorded in minutes.'}, {'measure': 'Lymphocyte Count', 'timeFrame': 'Preoperative to 24 hours postoperative.', 'description': 'Absolute lymphocyte count measured preoperatively and at 24 hours postoperatively.'}, {'measure': 'Neutrophil-to-Lymphocyte Ratio (NLR)', 'timeFrame': 'Preoperative to 24 hours postoperative.', 'description': 'NLR calculated from complete blood count values preoperatively and at 24 hours postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Knee Arthroplasty', 'Spinal Anesthesia', 'General Anesthesia', 'Delta Neutrophil Index', 'Inflammatory Response'], 'conditions': ['Inflammatory Response in Total Knee Arthroplasty']}, 'referencesModule': {'references': [{'pmid': '33067685', 'type': 'BACKGROUND', 'citation': 'Bozan MB, Yazar FM, Kale IT, Yuzbasioglu MF, Boran OF, Azak Bozan A. Delta Neutrophil Index and Neutrophil-to-Lymphocyte Ratio in the Differentiation of Thyroid Malignancy and Nodular Goiter. World J Surg. 2021 Feb;45(2):507-514. doi: 10.1007/s00268-020-05822-6. Epub 2020 Oct 16.'}, {'pmid': '18715852', 'type': 'BACKGROUND', 'citation': 'Nahm CH, Choi JW, Lee J. Delta neutrophil index in automated immature granulocyte counts for assessing disease severity of patients with sepsis. Ann Clin Lab Sci. 2008 Summer;38(3):241-6.'}], 'seeAlsoLinks': [{'url': 'https://elazigsehir.saglik.gov.tr/', 'label': 'Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effects of spinal versus general anesthesia on the inflammatory response measured by Delta Neutrophil Index (DNI) in patients undergoing total knee arthroplasty. The study is prospective and observational. A total of at least 84 patients will be included, with anesthesia type determined according to routine clinical practice. Preoperative and postoperative blood tests will be analyzed, and no additional blood samples will be required.', 'detailedDescription': 'This prospective observational study will be conducted at Elazig Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation. Patients undergoing total knee arthroplasty will be assigned to two groups based on the anesthesia method used in routine practice: spinal anesthesia or general anesthesia. The primary outcome measure is the Delta Neutrophil Index (DNI), an inflammation marker automatically calculated by hematology analyzers using complete blood count parameters. DNI values will be compared preoperatively and postoperatively between groups. Additional data including age, sex, ASA classification, duration of surgery, hemogram parameters, and perioperative complications will be collected. The sample size calculation indicated that a minimum of 42 patients per group (total 84) are required to detect significant differences in DNI levels with 80% power at a 5% significance level. Statistical analyses will include Kolmogorov-Smirnov test for normality, independent t test or Mann-Whitney U test for between-group comparisons, and paired t test or Wilcoxon test for within-group comparisons. A p-value \\<0.05 will be considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing elective total knee arthroplasty at Elazig Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for total knee arthroplasty\n* Age ≥ 18 years\n* ASA physical status classification I-III\n\nExclusion Criteria:\n\n* Active infection\n* Hematologic disease (e.g., leukemia, aplastic anemia)\n* Autoimmune or chronic inflammatory disease\n* Use of corticosteroids or immunosuppressive drugs\n* Malignancy\n* Acute trauma or sepsis\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT07214558', 'acronym': 'DNA-TKA', 'briefTitle': 'Spinal Versus General Anesthesia and Inflammatory Response Measured by Delta Neutrophil Index in Total Knee Arthroplasty: An Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Elazıg Fethi Sekin Sehir Hastanesi'}, 'officialTitle': 'he Effect of Spinal and General Anesthesia on Inflammatory Response Measured by Delta Neutrophil Index in Patients Undergoing Total Knee Arthroplasty: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'EFSH-ANES-2025-09-DELTANEUTROP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spinal Anesthesia Group', 'description': 'Patients undergoing total knee arthroplasty under spinal anesthesia. The choice of anesthesia is based on clinical decision-making in routine practice.', 'interventionNames': ['Other: Routine Clinical Anesthesia Practice']}, {'label': 'General Anesthesia Group', 'description': 'Patients undergoing total knee arthroplasty under general anesthesia. The choice of anesthesia is based on clinical decision-making in routine practice.', 'interventionNames': ['Other: Routine Clinical Anesthesia Practice']}], 'interventions': [{'name': 'Routine Clinical Anesthesia Practice', 'type': 'OTHER', 'description': "Patients undergoing total knee arthroplasty will receive either spinal or general anesthesia as determined by routine clinical practice and the attending anesthesiologist's decision. Investigators will not influence the choice of anesthesia method.", 'armGroupLabels': ['General Anesthesia Group', 'Spinal Anesthesia Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23200', 'city': 'Elâzığ', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Sciences, Elazığ Fethi Sekin City Hospital', 'geoPoint': {'lat': 38.67431, 'lon': 39.22321}}], 'overallOfficials': [{'name': 'Sevim Şenol Karataş', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared because the study is single-center, observational, and involves routine clinical laboratory results that are stored only in hospital records.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elazıg Fethi Sekin Sehir Hastanesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sevim Şenol Karataş', 'investigatorAffiliation': 'Elazıg Fethi Sekin Sehir Hastanesi'}}}}