Comparison Between Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
The aim of this study is to compare spinal and general anesthesia in neonates undergoing herniorrhaphy.
详细描述
Spinal anesthesia (SA) is a fast, simple and cost-effective method that has been used for the performance of inguinal hernias since the beginning of the 20th century in adults.
One large observational study documented a low risk of post operative events with spinal anesthesia for inguinal hernia repair in infants . In addition, a randomized trial comparing reginal and general anesthesia in this population have not shown any significant differences in outcome. Spinal anesthesia reduces postoperative oxygen desaturation and respiratory morbidity when compared to general anesthesia (GA) in infants who underwent inguinal herniorrhaphy
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
- None
入排标准
- 年龄范围
- 1 Day 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates either full term or preterm.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Undergoing unilateral or bilateral inguinal herniorrhaphy.
排除标准
- •Obstructed hernia.
- •Neonates with significant chronic lung disease (e.g., disease associated with hypoxemia in room air or chronic hypercapnia).
- •Symptomatic congenital heart disease (e.g., cyanosis or congestive heart failure).
- •Symptomatic central nervous system disease (e.g., seizures).
研究组 & 干预措施
Spinal Anesthesia
Oxygen supply will be done via nasal prong (2 L/min) when necessary. The local anesthetic used will be bupivacaine 0.6 mg/kg.
干预措施: Spinal anesthesia (Diagnostic Test)
General Anesthesia
Patients will receive sevoflurane for induction and maintenance in an air/oxygen mixture along. Endotracheal tube will be inserted. No opioids or nitrous oxide was used intraoperatively.
干预措施: General anesthesia (Diagnostic Test)
结局指标
主要结局
Heart rate
时间窗: Immediately postoperatively at post-anesthesia care unit
Heart rate will be recorded at post-anesthesia care unit.
次要结局
- Heart rate(Till two hours postoperatively)
- Need for postoperative O2 supplementation(Till two hours postoperatively)
- The duration of surgery(Till the end of surgery)
- Incidence of hypotension(24 hours postoperative)
- Mean arterial blood pressure(Till two hours postoperatively)
- Incidence of bradycardia(24 hours postoperative)
- Incidence of postoperative apnea(24 hour postoperatively)
- Hospital stays(28 days postoperative)
研究者
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University