Role of Lung Ultrasound in Comparison of Different Fluid Replacement Regimens in Pediatric Patients Undergoing Penile Hypospadias Repair, Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- volume overload using lung ultrasound
研究概览
简要总结
Optimization of perioperative fluid management is important for preventing adverse events, such as hypovolemia, cardiogenic shock, volume overload, and pulmonary edema, in both adult and pediatric patients. If the intravascular (IV) fluid volume is not optimized, pediatric patients are at risk of dehydration or volume overload. Perioperative IV fluid therapy is important during and after induction of general anesthesia (GA).The aim of this study is to investigate the difference between conventional and restrictive fluid replacement regimens using lung ultrasound in pediatric patients undergoing penile hypospadias repair, as a surgery with minor fluid loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •scheduled for repair of penile hypospadias with American Society of Anaesthesiologists' physical status of class I-II.
排除标准
- •Patients with pulmonary, cardiovascular, or hematological disorders or a family history of allergy to local anesthetics or lung disease
研究组 & 干预措施
conventional group, CG
receives Ringer's lactate solution at a rate of 4 ml/kg/h for the first-10 kg of body weight, 2 ml/kg/h for the second-10 kg of body weight, and 1 ml/kg/h for each further kg of body weight. The deficit volume is calculated as the maintenance volume multiplied by fasting hours and given as follows: 50% of the volume in the first hour, 25% of the volume in the second hour, and 25% of the volume in the third hour, in addition to the aforementioned maintenance volume
干预措施: lung ultrasound (Diagnostic Test)
restricted group, RG
Patients in the RG receives Ringer's lactate solution at a rate of 3 ml/kg/h from the start to the end of surgery.
干预措施: lung ultrasound (Diagnostic Test)
结局指标
主要结局
volume overload using lung ultrasound
时间窗: intraoperative duration that is approximately 110 minutes.
volume overload using lung ultrasound according to The mean number of B-lines detected on the ultrasound image
次要结局
未报告次要终点
研究者
Sherif Abdullah Mohamed
Principal investigator
Cairo University