An observational study in Renal Stone, Kidney; Complications and Ureter Stone, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Ankara City Hospital Bilkent · Observational
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.
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.
467 studies on the registry are indexed under Nephrolithiasis; 108 are open to participants now.
This study's enrollment of 136 is above the median of 96 across 84 observational studies indexed under Nephrolithiasis.
Browse Nephrolithiasis studies →Ankara City Hospital Bilkent is the lead sponsor of 437 studies on the registry; 109 are open to participants now.
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ASA I-III class between the ages of 1-18, patients who will undergo RIRS and URS surgery under standard general anesthesia, as well as patients who will undergo hypospadias surgery (without a history of stones or kidney problems).
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Exclusion Criteria:
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 · Other: Taking a blood sample
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 · Other: Taking a blood sample
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
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.
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.
Near infrared spectroscopy (NIRS)
Rretrograde intrarenal surgery (RIRS), ureteroscopy (URS) and hypospadias operations, renal oxygen level will be measured via NIRS monitor.
Time frame: NIRS values will be documented immediately prior to induction and every 5 minutes until recovery from anesthesia.
Infection parameters
Procalcitonin
Time frame: Preoperative and postoperative 24th hour
Infection parameters
Interleukin-6
Time frame: Preoperative and postoperative 24th hour
Infection parameters
C-reactive protein (CRP)
Time frame: Preoperative and postoperative 24th hour
Plan to share: No
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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