NephrolithiasisSAGEPCNLNCT07205224
Inflammatory Response Under Spinal vs General Anesthesia in PCNL: NLR, RDW, LAR.
An observational study of Nephrolithiasis and Postoperative Inflammation, run by Sevim Şenol Karataş at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Nephrolithiasis, Postoperative Inflammation
- What is being tested?
- Anesthesia Type
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Sep 2025to 22 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥18 years
- ASA physical status I-III
- Scheduled for percutaneous nephrolithotomy (PCNL)
- Provided informed consent
Who cannot join
- Active infection or sepsis
- Known malignancy
- Chronic inflammatory or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus)
- Current immunosuppressive therapy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Elazığ Fethi Sekin City Hospital
Elâzığ, Merkez, 23200
About this study
Official 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)
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.
Read the detailed description
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
- Nephrolithiasis, Postoperative Inflammation
- Being tested
- Anesthesia Type
- Keywords
- Percutaneous Nephrolithotomy, PCNL, Spinal Anesthesia, General Anesthesia, Inflammatory Response, Neutrophil-to-Lymphocyte Ratio (NLR), Red Cell Distribution Width (RDW), Lactate-to-Albumin Ratio (LAR)
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia TypeOther
Patients receive either spinal or general anesthesia according to routine clinical decision-making. No investigational drug or device is administered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Anesthesia Type |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (≤6 hours preoperative) and 24 hours postoperatively
Secondary outcomes (3)
Change in Red Cell Distribution Width (ΔRDW)
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.
Measured: Baseline (≤6 hours preoperative) and 24 hours postoperatively
Change in Lactate-to-Albumin Ratio (ΔLAR)
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.
Measured: aseline (≤6 hours preoperative) and 24 hours postoperatively
Postoperative Complications
Occurrence of any PCNL-related complications (e.g., bleeding, infection) during index hospitalization.
Measured: From surgery until hospital discharge (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start22 Sep 2025
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sevim Şenol Karataş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi
- Investigators
- Sevim Şenol Karataş, Principal investigator, Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205224
- Sponsor's protocol ID
- EFSH-ANES-2025-09-PERCUTANE
- Acronym
- SAGEPCNL
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 37223489Wongyingsinn 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.
PubMed 33253306Indra 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.
PubMed 38618023
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07205224
- Acronym / sponsor ID
- SAGEPCNL / EFSH-ANES-2025-09-PERCUTANE
- Conditions
- Nephrolithiasis, Postoperative Inflammation
- Keywords
- Percutaneous Nephrolithotomy, PCNL, Spinal Anesthesia, General Anesthesia, Inflammatory Response, Neutrophil-to-Lymphocyte Ratio (NLR), Red Cell Distribution Width (RDW), Lactate-to-Albumin Ratio (LAR)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sevim Şenol KarataşUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia Cohort | – | Other: Anesthesia TypeAdult 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. |
| General Anesthesia Cohort | – | Other: Anesthesia TypeAdult 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age ≥18 years
- ASA physical status I-III
- Scheduled for percutaneous nephrolithotomy (PCNL)
- Provided informed consent
Key exclusion criteria (5 listed)
- Active infection or sepsis
- Known malignancy
- Chronic inflammatory or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus)
- Current immunosuppressive therapy
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia TypePatients receive either spinal or general anesthesia according to routine clinical decision-making. No investigational drug or device is administered. | Other | General Anesthesia Cohort, Spinal Anesthesia Cohort |
Primary outcome
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.
3 secondary outcomes
Change in Red Cell Distribution Width (ΔRDW)
Time frame: Baseline (≤6 hours preoperative) and 24 hours postoperatively
Change in Lactate-to-Albumin Ratio (ΔLAR)
Time frame: aseline (≤6 hours preoperative) and 24 hours postoperatively
Postoperative Complications
Time frame: From surgery until hospital discharge (up to 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Background: PubMed 37223489Sankar 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.
- Background: PubMed 33253306Wongyingsinn 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.
- Background: PubMed 38618023Indra 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.
- Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and ReanimationLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevim Şenol Karataş principal investigator
Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrolithiasis and Postoperative Inflammation, run by Sevim Şenol Karataş at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neutrophil-to-Lymphocyte Ratio (ΔNLR) (time frame: Baseline (≤6 hours preoperative) and 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07205224, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.