Clinical Trials Directory

Trials / Completed

CompletedNCT07214558

Spinal Versus General Anesthesia and Inflammatory Response Measured by Delta Neutrophil Index in Total Knee Arthroplasty: An Observational Study

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

Status
Completed
Phase
Study type
Observational
Enrollment
84 (actual)
Sponsor
Elazıg Fethi Sekin Sehir Hastanesi · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERRoutine Clinical Anesthesia PracticePatients 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.

Timeline

Start date
2025-09-22
Primary completion
2025-10-22
Completion
2025-10-22
First posted
2025-10-09
Last updated
2025-11-26

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07214558. Inclusion in this directory is not an endorsement.