Evaluation of Renal Oxygenation by NIRS in Pediatric Endourologic Stone Surgery

Study Overview
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Brief Summary
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The study aims to compare renal oxygenation levels in retrograde intrarenal surgery (RIRS) and ureteroscopy (URS) procedures with a control group. Additionally, it seeks to determine if there is a connection between postoperative infection parameters and intraoperative renal oxygenation measurements.

Detailed Description
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The study will involve ASA class I-III pediatric patients aged 1-18 undergoing RIRS, URS, and hypospadias surgery under general anesthesia. Patients will be divided into three groups: Group R (RIRS), Group U (URS), and Group H (Hypospadias/Control). Data collection will include patient height and weight. In Groups R and U, pre- and postoperative measurements such as hemoglobin, hematocrit, leukocyte count, BUN, serum creatinine, procalcitonin, interleukin-6, and CRP values will be recorded. All three groups will undergo NIRS monitoring alongside routine ASA monitoring. Renal NIRS probes will be positioned using ultrasonography, and the average of three measurements will determine the regional oxygen saturation index (rSO2) as the initial value. NIRS, pulse oximetry, and hemodynamic data will be recorded every 5 minutes until recovery from anesthesia just prior to induction. A decrease of 20% or more than 20% when comparing NIRS values during follow-up with the baseline will be considered significant. The study will also document anesthesia and surgery times, as well as postoperative fever and the amount of irrigation fluid used in Groups R and U.

Official Title
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Evaluation of Renal Oxygenation in Pediatric Retrograde Intrarenal Surgery (RIRS) and Ureteroscopy (URS) Procedures by Near Infrared Spectroscopy (NIRS)

Conditions
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Renal Stone, Kidney; Complications, Ureter Stone, Renal Oxygenation

Intervention / Treatment
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* Device: NIRS
* Other: Taking a blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1-18 years ASA I-III class, Patients who will undergo RIRS, URS and Hypospadias surgeries under standard general anesthesia. Patients whose informed consent form is approved by their parents will be included in the study. Exclusion Criteria: Exclusio criteria were the history of renal failure, renal tumors, infection of the perirenal region; receiving colloid or blood transfusion, having abscess, body mass index (BMI) not in the normal limits (≤3% or ≥97%) Patients whose parents do not approve the informed consent form will not be included in the study.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group R<br>Pre- and Postoperative hemoglobin (Hb), hematocrit (Htc), leukocyte (WBC), blood urea nitrogen (BUN), serum creatinine (sCr), procalcitonin, interleukin-6 and CRP values will be recorded. NIRS monitoring will be performed in addition to routine ASA monitoring. After the positions of the renal NIRS probes are confirmed by ultrasonography, the average value of the three measurements will be taken and the regional oxygen saturation index (rSO2) will be accepted as the initial value. NIRS, pulse oximetry, and hemodynamic data will be recorded every 5 minutes until recovery from anesthesia just prior to induction. When comparing the NIRS values measured during follow-up with the baseline NIRS value, a decrease of 20% or more than 20% will be considered significant. Anesthesia and surgery times will also be recorded. Postoperative fever and the amount of irrigation fluid used during the surgical procedure will be recorded . | Device: NIRS<br>* After the positions of the renal NIRS probes are confirmed by ultrasonography, the average value of the three measurements will be taken and the regional oxygen saturation index (rSO2) will be accepted as the initial value.<br>Other: Taking a blood sample<br>* Pre- and Postoperative hemoglobin (Hb), hematocrit (Htc), leukocyte (WBC), blood urea nitrogen (BUN), serum creatinine (sCr), procalcitonin, interleukin-6 and CRP values will be recorded.<br>|
| Group U<br>Pre- and Postoperative hemoglobin (Hb), hematocrit (Htc), leukocyte (WBC), blood urea nitrogen (BUN), serum creatinine (sCr), procalcitonin, interleukin-6 and CRP values will be recorded. NIRS monitoring will be performed in addition to routine ASA monitoring. After the positions of the renal NIRS probes are confirmed by ultrasonography, the average value of the three measurements will be taken and the regional oxygen saturation index (rSO2) will be accepted as the initial value. NIRS, pulse oximetry, and hemodynamic data will be recorded every 5 minutes until recovery from anesthesia just prior to induction. When comparing the NIRS values measured during follow-up with the baseline NIRS value, a decrease of 20% or more than 20% will be considered significant. Anesthesia and surgery times will also be recorded. Postoperative fever and the amount of irrigation fluid used during the surgical procedure will be recorded . | Device: NIRS<br>* After the positions of the renal NIRS probes are confirmed by ultrasonography, the average value of the three measurements will be taken and the regional oxygen saturation index (rSO2) will be accepted as the initial value.<br>Other: Taking a blood sample<br>* Pre- and Postoperative hemoglobin (Hb), hematocrit (Htc), leukocyte (WBC), blood urea nitrogen (BUN), serum creatinine (sCr), procalcitonin, interleukin-6 and CRP values will be recorded.<br>|
| Group H<br>The study involves continuous NIRS monitoring in addition to routine ASA monitoring. To establish the initial value of regional oxygen saturation (rSO2), renal NIRS probes will be positioned using ultrasonography, and an average of three measurements will be taken. Throughout the procedure, NIRS data, along with pulse oximetry and hemodynamic data, will be recorded at 5-minute intervals until the patient recovers from anesthesia just prior to induction. Significant changes in NIRS values will be determined if a decrease of 20% or more compared to the baseline measurement is observed. Anesthesia and surgery times will also be recorded. | Device: NIRS<br>* After the positions of the renal NIRS probes are confirmed by ultrasonography, the average value of the three measurements will be taken and the regional oxygen saturation index (rSO2) will be accepted as the initial value.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near infrared spectroscopy (NIRS) | Rretrograde intrarenal surgery (RIRS), ureteroscopy (URS) and hypospadias operations, renal oxygen level will be measured via NIRS monitor. | NIRS values will be documented immediately prior to induction and every 5 minutes until recovery from anesthesia. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection parameters | Procalcitonin | Preoperative and postoperative 24th hour | 
| Infection parameters | Interleukin-6 | Preoperative and postoperative 24th hour | 
| Infection parameters | C-reactive protein (CRP) | Preoperative and postoperative 24th hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Near infrared spectroscopy, Pediatric, Renal oxygenation, Endourologic stone surgery, infectious complication