Evaluation of Renal Oxygenation by NIRS in Pediatric Endourologic Stone Surgery

Renal Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06110247
• Other study ID #: NIRS
• Status: Active, not recruiting
• Start date: November 3, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 136
• Est. completion date: April 30, 2024
• Est. primary completion date: March 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Renal Stone
• Ureter Stone

Intervention

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.

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.

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital,Department Of Anesthesiology and Reanimation	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Infection parameters	Procalcitonin	Preoperative and postoperative 24th hour
Secondary	Infection parameters	Interleukin-6	Preoperative and postoperative 24th hour
Secondary	Infection parameters	C-reactive protein (CRP)	Preoperative and postoperative 24th hour