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

NCT ID: NCT07205224

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-22

Study Completion Date

2025-10-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nephrolithiasis Postoperative Inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Anesthesia Type

Intervention Type OTHER

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

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.

Anesthesia Type

Intervention Type OTHER

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

Interventions

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Anesthesia Type

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sevim Şenol Karataş

OTHER

Sponsor Role lead

Responsible Party

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Sevim Şenol Karataş

Principal Investigator,

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sevim Şenol Karataş

Role: PRINCIPAL_INVESTIGATOR

Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation

Locations

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Elazığ Fethi Sekin City Hospital

Elâzığ, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 37223489 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33253306 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38618023 (View on PubMed)

Related Links

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https://elazigsehir.saglik.gov.tr/

Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation

Other Identifiers

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EFSH-ANES-2025-09-PERCUTANE

Identifier Type: -

Identifier Source: org_study_id

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