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Completed

NCT Number: NCT06110247

Evaluation of Renal Oxygenation by NIRS in Pediatric Endourologic Stone Surgery

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.

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital,Department Of Anesthesiology and Reanimation

Ankara, Çankaya, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NIRS

Device

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.

Taking a blood sample

Other

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.

Primary outcomes

  1. Near infrared spectroscopy (NIRS)

    Time frame: 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 outcomes

  1. Infection parameters

    Time frame: Preoperative and postoperative 24th hour

    Procalcitonin

  2. Infection parameters

    Time frame: Preoperative and postoperative 24th hour

    Interleukin-6

  3. Infection parameters

    Time frame: Preoperative and postoperative 24th hour

    C-reactive protein (CRP)

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2023
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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