NCT07214558

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 22, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 9, 2025

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2025

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

1 month

First QC Date

September 22, 2025

Last Update Submit

November 25, 2025

Conditions

Keywords

Total Knee ArthroplastySpinal AnesthesiaGeneral AnesthesiaDelta Neutrophil IndexInflammatory Response

Outcome Measures

Primary Outcomes (1)

  • Change in Delta Neutrophil Index (DNI)

    Difference in DNI values measured preoperatively and postoperatively in patients undergoing total knee arthroplasty under spinal versus general anesthesia.

    From baseline (preoperative) to 24 hours postoperative.

Secondary Outcomes (5)

  • Neutrophil Count

    Preoperative to 24 hours postoperative.

  • Perioperative Complications

    Intraoperative and during hospital stay (up to 7 days).

  • Operative Time

    Intraoperative period.

  • Lymphocyte Count

    Preoperative to 24 hours postoperative.

  • Neutrophil-to-Lymphocyte Ratio (NLR)

    Preoperative to 24 hours postoperative.

Study Arms (2)

Spinal Anesthesia Group

Patients undergoing total knee arthroplasty under spinal anesthesia. The choice of anesthesia is based on clinical decision-making in routine practice.

Other: Routine Clinical Anesthesia Practice

General Anesthesia Group

Patients undergoing total knee arthroplasty under general anesthesia. The choice of anesthesia is based on clinical decision-making in routine practice.

Other: Routine Clinical Anesthesia Practice

Interventions

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.

General Anesthesia GroupSpinal Anesthesia Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing elective total knee arthroplasty at Elazig Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation.

You may qualify if:

  • Patients scheduled for total knee arthroplasty
  • Age ≥ 18 years
  • ASA physical status classification I-III

You may not qualify if:

  • Active infection
  • Hematologic disease (e.g., leukemia, aplastic anemia)
  • Autoimmune or chronic inflammatory disease
  • Use of corticosteroids or immunosuppressive drugs
  • Malignancy
  • Acute trauma or sepsis
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Elazığ Fethi Sekin City Hospital

Elâzığ, Merkez, 23200, Turkey (Türkiye)

Location

Related Publications (2)

  • 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: 33067685BACKGROUND
  • 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.

    PMID: 18715852BACKGROUND

Related Links

Study Officials

  • Sevim Şenol Karataş

    Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2025

First Posted

October 9, 2025

Study Start

September 22, 2025

Primary Completion

October 22, 2025

Study Completion

October 22, 2025

Last Updated

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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.

Locations