Evaluation of Renal Oxygenation by NIRS in Pediatric Endourologic Stone Surgery

Completed

• Conditions: Renal Stone; Renal Oxygenation; Ureter Stone; Kidney; Complications

• Registration Number: NCT06110247
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-10-26
• Study First Posted: 2023-10-31
• Study Start: 2023-11-03
• Primary Completion: 2024-03-07
• Study Completion: 2024-04-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Infection parameters	Preoperative and postoperative 24th hour	C-reactive protein (CRP)

Trial Locations

Locations (1)

Ankara Bilkent City Hospital,Department Of Anesthesiology and Reanimation; 🇹🇷 Ankara, Çankaya, Turkey