Efficacy, Safety and Limitations of Spinal Block When Used for All Infants Under 3 Months of Age Scheduled for Lower Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- the success rate of spinal block in abdominal surgeries in infants under 3 months of age.
研究概览
简要总结
Spinal anesthesia (SA) has been shown to be a viable alternative to general anesthesia (GA) for infants and children for a variety of surgical procedures. SA serves to avoid some of the potential risks of GA including the need for airway manipulation, hemodynamic instability, postoperative apnea, and exposure to medications that may cause neurotoxicity .SA allows the prevention and reduction of perioperative complications even if its duration is an important limiting factor. Because of this limitation, short surgery is the most indicated under SA . Premature infants and neurologically impaired children account for the majority of spinal anesthetics used today .
This study evaluates the effectiveness, safety and limitations of spinal anesthesia when used for all infants under 3 months undergoing lower abdominal surgery at Ain Shams University Hospitals.
详细描述
Patients will be carefully examined 24 hours (h) to the procedure and every case will be assessed individually concerning its eligibility for spinal anesthesia under the supervision of a senior pediatric anesthesiologist. History taking and clinical examination along with the necessary laboratory tests . Standard blood test is cbc and we will use it a routine before surgery. About 1 ml blood is needed as a sample.
Counseling the parents or the legal guardian regarding every aspect of the procedure and obtaining their informed written consent.
All patients will be fasting from formula milk for 6 hours, breast milk for 4 hours and clear fluid for 1 h before anesthesia . No overnight premedication will be given.
After the establishment of intravenous access, all patients will be given crystalloid solution (Ringer's solution or Normal Saline) of 10 ml/kg over 30 minutes started with the application of monitors. Heart rate, blood pressure, oxygen saturation. Blood glucose level is measured.
The monitors will be connected and pulse oximetry (SPO2) baseline non-invasive blood pressure (NIBP), heart rate (HR), and electrocardiogram (ECG tracings) will be obtained. Fluid bolus of 5 ml/kg will be used for any intraoperative hypotension. Atropine 50µ/kg will be given intravenously if HR dropped > 20% of baseline reading . Intraoperative blood loss will be replaced by 3 times volume with the same crystalloid .blood glucose level is measured after injection then every 30 minutes till end of surgery .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age under 3 months.
- •Physical status: American Society of Anesthesiologists I - II.
- •Elective lower abdominal surgeries such as: hernia, hydrocele, undescended testis
排除标准
- •Patient's parents or legal guardian refusing to do this specific procedure.
- •Coagulopathy, use of anti-coagulant or antiplatelet therapy.
- •Infection at the site of injection.
结局指标
主要结局
the success rate of spinal block in abdominal surgeries in infants under 3 months of age.
时间窗: during the surgery
Success rate = (no of total patients - no of all converted general anesthesia patients) divided by no of total cases%.
次要结局
- Duration of spinal block in minutes(during the surgery)
- Number of attempts(during the surgery)
- Depth of insertion of the spinal needle(during the surgery)
- Blood glucose level(every 30 minutes till end of surgery)
- Determine the incidence of complications(after spinal block to end of surgery)