Effects of Spinal vs General Anesthesia on Systemic Inflammation in PCNL (PCNL-ANES-INF)

April 21, 2026 updated by: Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi

Comparison of Spinal and General Anesthesia on Systemic Inflammatory Response in Patients Undergoing Percutaneous Nephrolithotomy: Evaluation of SII, SIRI, AISI, NLR, and RDW

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative change in systemic inflammatory indices (SII, SIRI, AISI, NLR, RDW)
Time Frame: From preoperative period (within 6 hours before surgery) to postoperative period (6-24 hours after surgery)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elazıg Fethi Sekin Sehir Hastanesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2025

Primary Completion (Estimated)

April 25, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

December 24, 2025

First Submitted That Met QC Criteria

December 24, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PCNL-ANES-INFLAM-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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