NCT07326670

Brief Summary

This observational study aims to compare the effects of spinal and general anesthesia on perioperative systemic inflammatory response in patients undergoing percutaneous nephrolithotomy (PCNL). Systemic inflammatory indices derived from routine complete blood count parameters, including Systemic Immune-Inflammation Index (SII), Systemic Inflammation Response Index (SIRI), Aggregate Index of Systemic Inflammation (AISI), Neutrophil-to-Lymphocyte Ratio (NLR), and Red Cell Distribution Width (RDW), will be evaluated. Preoperative and postoperative laboratory values will be analyzed to determine whether the type of anesthesia influences systemic inflammatory markers and related clinical outcomes.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

December 24, 2025

Last Update Submit

April 21, 2026

Conditions

Keywords

Percutaneous nephrolithotomySpinal anesthesiaNeutrophil-to-lymphocyte ratioRed cell distribution widthSystemic inflammation

Outcome Measures

Primary Outcomes (1)

  • Perioperative change in systemic inflammatory indices (SII, SIRI, AISI, NLR, RDW)

    Changes in Systemic Immune-Inflammation Index (SII), Systemic Inflammation Response Index (SIRI), Aggregate Index of Systemic Inflammation (AISI), Neutrophil-to-Lymphocyte Ratio (NLR), and Red Cell Distribution Width (RDW) will be evaluated using routine complete blood count parameters obtained preoperatively and postoperatively.

    From preoperative period (within 6 hours before surgery) to postoperative period (6-24 hours after surgery)

Study Arms (2)

Spinal Anesthesia Group

Patients undergoing percutaneous nephrolithotomy under spinal anesthesia as part of routine clinical practice. No additional intervention is performed for the purposes of the study.

General Anesthesia Group

Patients undergoing percutaneous nephrolithotomy under general anesthesia as part of routine clinical practice. No additional intervention is performed for the purposes of the study.

Eligibility Criteria

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

The study population consists of adult patients aged 18 years and older who undergo elective percutaneous nephrolithotomy (PCNL) surgery and meet the eligibility criteria. Patients classified as American Society of Anesthesiologists (ASA) physical status I-III are included. All participants receive either spinal or general anesthesia as part of routine clinical practice, and no additional intervention is performed for research purposes.

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status class I-III
  • Patients aged 18 years and older

You may not qualify if:

  • American Society of Anesthesiologists (ASA) physical status class IV or V
  • Patients younger than 18 years
  • Active infection or diagnosis of sepsis
  • Malignancy
  • Chronic inflammatory diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus)
  • Use of immunosuppressive therapy
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fethi Sekin City Hospital

Elâzığ, Elaziğ, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Sevim ŞENOL KARATAŞ, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Anesthesiology and Reanimation

Study Record Dates

First Submitted

December 24, 2025

First Posted

January 8, 2026

Study Start

October 15, 2025

Primary Completion

April 25, 2026

Study Completion

April 30, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations