NCT07205224

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

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
11 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
19 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

Percutaneous NephrolithotomyPCNLSpinal AnesthesiaGeneral AnesthesiaInflammatory ResponseNeutrophil-to-Lymphocyte Ratio (NLR)Red Cell Distribution Width (RDW)Lactate-to-Albumin Ratio (LAR)

Outcome Measures

Primary Outcomes (1)

  • Change in Neutrophil-to-Lymphocyte Ratio (ΔNLR)

    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.

    Baseline (≤6 hours preoperative) and 24 hours postoperatively

Secondary Outcomes (3)

  • Change in Red Cell Distribution Width (ΔRDW)

    Baseline (≤6 hours preoperative) and 24 hours postoperatively

  • Change in Lactate-to-Albumin Ratio (ΔLAR)

    aseline (≤6 hours preoperative) and 24 hours postoperatively

  • Postoperative Complications

    From surgery until hospital discharge (up to 7 days)

Study Arms (2)

Spinal Anesthesia Cohort

Adult patients (≥18 years, ASA I-III) undergoing percutaneous nephrolithotomy (PCNL) under spinal anesthesia. Routine perioperative laboratory values (NLR, RDW, LAR) will be recorded preoperatively and postoperatively.

Other: Anesthesia Type

General Anesthesia Cohort

Adult patients (≥18 years, ASA I-III) undergoing percutaneous nephrolithotomy (PCNL) under general anesthesia. Routine perioperative laboratory values (NLR, RDW, LAR) will be recorded preoperatively and postoperatively.

Other: Anesthesia Type

Interventions

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

General Anesthesia CohortSpinal Anesthesia Cohort

Eligibility Criteria

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

Adult patients (≥18 years, ASA I-III) scheduled for percutaneous nephrolithotomy (PCNL) at a single tertiary care center. Eligible patients will be assigned to spinal or general anesthesia groups based on routine clinical decision-making. Routine perioperative laboratory values (NLR, RDW, LAR) will be collected preoperatively and postoperatively.

You may qualify if:

  • Age ≥18 years
  • ASA physical status I-III
  • Scheduled for percutaneous nephrolithotomy (PCNL)
  • Provided informed consent

You may not qualify if:

  • Active infection or sepsis
  • Known malignancy
  • Chronic inflammatory or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus)
  • Current immunosuppressive therapy
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, Merkez, 23200, Turkey (Türkiye)

Location

Related Publications (3)

  • Sankar K, Anand K, Ramani S, Gayathri B. A Randomized Control Trial to Compare Hemodynamic Parameters of Patients Undergoing Percutaneous Nephrolithotomy Under Combined Spinal-Epidural and General Anesthesia in a Tertiary Hospital. Local Reg Anesth. 2023 May 18;16:41-49. doi: 10.2147/LRA.S410510. eCollection 2023.

    PMID: 37223489BACKGROUND
  • Wongyingsinn M, Kohmongkoludom P, Trakarnsanga A, Horthongkham N. Postoperative clinical outcomes and inflammatory markers after inguinal hernia repair using local, spinal, or general anesthesia: A randomized controlled trial. PLoS One. 2020 Nov 30;15(11):e0242925. doi: 10.1371/journal.pone.0242925. eCollection 2020.

    PMID: 33253306BACKGROUND
  • Indra Rachman R, Birowo P, Nurullah G, Cho PSY, Atmoko W, Widyahening IS, Rasyid N. General versus spinal anesthesia in percutaneous nephrolithotomy: A systematic review and meta-analysis. F1000Res. 2023 Nov 1;12:281. doi: 10.12688/f1000research.124704.2. eCollection 2023.

    PMID: 38618023BACKGROUND

Related Links

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

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
SPONSOR INVESTIGATOR
PI Title
Principal Investigator,

Study Record Dates

First Submitted

September 22, 2025

First Posted

October 3, 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 uses routine clinical laboratory results and institutional restrictions do not allow sharing of raw patient-level data. Only de-identified aggregate results will be published in peer-reviewed journals upon request.

Locations