Anesthesia TechniquesPCNL-ANES-INFNCT07326670
Effects of Spinal vs General Anesthesia on Systemic Inflammation in PCNL
An observational study of Anesthesia Techniques and Percutaneous Nephrolithotomy, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to compare the effects of spinal and general anesthesia on perioperative systemic inflammatory response in patients undergoing percutaneous nephrolithotomy (PCNL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia Techniques, Percutaneous Nephrolithotomy, Systemic Inflammation
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Nov 2025to 25 Apr 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status class I-III
- Patients aged 18 years and older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- Percutaneous nephrolithotomy, Spinal anesthesia, Neutrophil-to-lymphocyte ratio, Red cell distribution width, Systemic inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Perioperative change in systemic inflammatory indices (SII, SIRI, AISI, NLR, RDW)
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.
Measured: From preoperative period (within 6 hours before surgery) to postoperative period (6-24 hours after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start7 Nov 2025
- Primary completion25 Apr 2026
- Study completion25 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia TechniquesStudies 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
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326670
- Sponsor's protocol ID
- PCNL-ANES-INFLAM-2025
- Acronym
- PCNL-ANES-INF
- Status last verified
- Jun 2026
- First submitted
- 24 Dec 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Spinal and General Anesthesia on Systemic Inflammatory Response in Patients Undergoing Percutaneous Nephrolithotomy: Evaluation of SII, SIRI, AISI, NLR, and RDW
- ClinicalTrials.gov ID
- NCT07326670
- Acronym / sponsor ID
- PCNL-ANES-INF / PCNL-ANES-INFLAM-2025
- Keywords
- Percutaneous nephrolithotomy, Spinal anesthesia, Neutrophil-to-lymphocyte ratio, Red cell distribution width, Systemic inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- 25 Apr 2026 (actual)
- First posted
- 8 Jan 2026 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status class I-III
- Patients aged 18 years and older
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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 22 Jun 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anesthesia Techniques and Percutaneous Nephrolithotomy, run by Elazıg Fethi Sekin Sehir Hastanesi 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 2 inclusion and 7 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 22 Jun 2026. 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?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026.