Comparison of perioperative outcomes between ultrasound guided caudal block with sedation versus general anaesthesia in paediatric patients undergoing infraumbilical surgery.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To determine the percentage of patients who completed surgery using only regional anesthesia without getting converted to general anesthesia.
研究概览
简要总结
Infraumbilical surgeries, such as inguinal hernia repair, orchidopexy, and hypospadias correction, are among the most common procedures performed in paediatric patients. These surgeries are typically conducted under general anaesthesia combined with a caudal block worldwide. However, paediatric patients undergoing general anaesthesia for infraumbilical surgeries face risk of perioperative cardiorespiratory adverse events. Performing these surgeries exclusively under caudal block with ketamine and dexmed as sedation can help preserve airway tone and potentially reduce these risks. This study aims to compare perioperative conditions and adverse events between two approaches dexmedetomidine sedation with caudal block versus general anaesthesia with caudal block, for infraumbilical surgeries in paediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •Paeditric patients between age of 06 months to 06 years,both ASA I & II undergoing infraumbilical surgeries will be included.
排除标准
- •1 Any syndromic patient with suspected difficult airway 2 Any patient with sacrococcygeal anomaly 3 Any contraindication for sevoflurane, ketamine, dexmedetomidine or ropivacaine 4 Anticipated difficult or prolonged surgeries more than 2 hours 5 Weight of less than 3 kilogram.
结局指标
主要结局
To determine the percentage of patients who completed surgery using only regional anesthesia without getting converted to general anesthesia.
时间窗: within 2 hours of start of the surgery.
次要结局
- Duration of anaesthesia, duration of surgery, time to start surgery, wake up time, total duration in the operative room, total duration in the PACU, time to successful caudal placement, number of attempts at caudal placement, intraoperative haemodynamics and any perioperative adverse events.(Success rate of the ultrasound guided caudal block with sedation technique with no perioperative adverse event 12 hours post surgery with no protocol violations.)
研究者
Dr RAJIT KUMAR
Command Hospital Southern Command,Pune