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临床试验/NCT06110247
NCT06110247已完成不适用

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

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2023年11月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
136
试验地点
1
主要终点
Near infrared spectroscopy (NIRS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Near infrared spectroscopy (NIRS)

时间窗: 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.

次要结局

  • Infection parameters(Preoperative and postoperative 24th hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Şengül Özmert

Assoc. Prof. MD

Ankara City Hospital Bilkent

研究点 (1)

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