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Completed

NCT Number: NCT07205224

Inflammatory Response Under Spinal vs General Anesthesia in PCNL: NLR, RDW, LAR.

This observational study compares the effects of spinal versus general anesthesia on the perioperative systemic inflammatory response in adults undergoing PCNL. Routine clinical laboratory values (NLR, RDW, LAR) obtained preoperatively and postoperatively will be recorded to evaluate between-group and within-group changes. No additional blood sampling will be performed beyond standard care.

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Key information

Conditions

Nephrolithiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Postoperative Inflammation Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Elazığ Fethi Sekin City Hospital

Elâzığ, Merkez, 23200, Turkey (Türkiye)

About this study

The study will be conducted at the Department of Anesthesiology and Reanimation, Elazığ Fethi Sekin City Hospital, among adult patients scheduled for PCNL (ASA I-III). The anesthesia type (spinal vs general) is determined by clinical requirements; investigators do not influence this choice.

Sampling windows:

Preoperative: within ≤6 hours before surgery

Postoperative: first sample obtained within 6-24 hours after surgery Parameters: NLR (neutrophil/lymphocyte), RDW, LAR; plus age, sex, ASA class, operative time, and in-hospital complications.

Statistics: Normality testing; between-group comparisons by independent t-test or Mann-Whitney U; within-group by paired t-test or Wilcoxon; categorical by chi-square; p<0.05 significant. Power considerations target ≥45 per group (total ≥90). No extra biospecimens will be collected beyond routine care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥18 years

ASA physical status I-III

Scheduled for percutaneous nephrolithotomy (PCNL)

Provided informed consent

Exclusion criteria

Active infection or sepsis

Known malignancy

Chronic inflammatory or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus)

Current immunosuppressive therapy

Pregnancy

Treatment and study plan

Anesthesia Type

Other

Patients receive either spinal or general anesthesia according to routine clinical decision-making. No investigational drug or device is administered.

Primary outcomes

  1. Change in Neutrophil-to-Lymphocyte Ratio (ΔNLR)

    Time frame: Baseline (≤6 hours preoperative) and 24 hours postoperatively

    Difference in neutrophil-to-lymphocyte ratio (NLR) between preoperative (≤6 hours before surgery) and postoperative (6-24 hours after surgery) blood samples in spinal vs general anesthesia groups.

Secondary outcomes

  1. Change in Red Cell Distribution Width (ΔRDW)

    Time frame: Baseline (≤6 hours preoperative) and 24 hours postoperatively

    Difference in RDW values between preoperative (≤6 hours before surgery) and postoperative (6-24 hours after surgery) blood samples in spinal vs general anesthesia groups.

  2. Change in Lactate-to-Albumin Ratio (ΔLAR)

    Time frame: aseline (≤6 hours preoperative) and 24 hours postoperatively

    Difference in LAR values between preoperative (≤6 hours before surgery) and postoperative (6-24 hours after surgery) blood samples in spinal vs general anesthesia groups.

  3. Postoperative Complications

    Time frame: From surgery until hospital discharge (up to 7 days)

    Occurrence of any PCNL-related complications (e.g., bleeding, infection) during index hospitalization.

Sponsors and collaborators

Lead sponsor

Sevim Şenol Karataş

Other

Registry information

Official study title

Effects of Spinal Versus General Anesthesia on Perioperative Inflammatory Response in Percutaneous Nephrolithotomy (PCNL): The Role of Neutrophil-to-Lymphocyte Ratio (NLR), Red Cell Distribution Width (RDW), and Lactate-to-Albumin Ratio (LAR)

Acronym: SAGEPCNL

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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