Safety Control Study in Pediatric Inguinal Hernia Repair: Are Muscle Relaxants Necessary? Endotracheal Intubation vs Laryngeal Mask Airway
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
- Intraabdominal Pressure
研究概览
简要总结
In prospective, safety-control study; children undergoing laparoscopic inguinal hernia repair using PIRS (Percutaneous Internal Ring Suturing) method will be randomly assigned into four groups. Gr 1: Endotracheal intubation and muscle relaxant, Gr 2: Endotracheal Intubation without muscle relaxant, Gr 3: Proseal Laryngeal Mask Airway without muscle relaxant, Gr 4: Proseal Laryngeal Mask Airway with subparalytic does muscle relaxant. Apart from standard monitorization, all patients' intragastric pressures will also be monitored. Patients' age at presentation, gender, time of surgery, time of anesthesia, intragastric pressure, intraabdominal pressure, intraoperative findings and complications will be noted and compared between groups.
详细描述
In this prospective, safety-control study; children undergoing laparoscopic inguinal hernia repair using PIRS (Percutaneous Internal Ring Suturing) method will be randomly assigned into four groups.
Gr 1: Endotracheal intubation and muscle relaxant, Gr 2: Endotracheal Intubation without muscle relaxant, Gr 3: Proseal Laryngeal Mask Airway without muscle relaxant, Gr 4: Proseal Laryngeal Mask Airway with subparalytic does muscle relaxant.
Apart from standard monitorization, all patients' intragastric pressures will also be monitored. Patients' age at presentation, gender, time of surgery, time of anesthesia, intragastric pressure, intraabdominal pressure, intraoperative findings and complications will be noted and compared between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 0-18 years
- •Diagnosed with inguinal hernia or communicating hydrocele
- •Due to undergo laparoscopic inguinal hernia repair
排除标准
- •Previous abdominal surgery
- •Comorbidities that will effect surgical time, time under anesthesia, intragastric pressure and abdominal pressure
研究组 & 干预措施
ETT & Muscle Relaxant
Children undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and Muscle Relaxant
干预措施: ETT (Device)
ETT & Muscle Relaxant
Children undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and Muscle Relaxant
干预措施: Rocuronium (Drug)
ETT & No Muscle Relaxant
Children undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and No Muscle Relaxant
干预措施: ETT (Device)
ETT & No Muscle Relaxant
Children undergoing laparoscopic inguinal hernia repair using PIRS method with Endotracheal Intubation and No Muscle Relaxant
干预措施: No Muscle Relaxant (Other)
Proseal LMA & No Muscle Relaxant
Children undergoing laparoscopic inguinal hernia repair using PIRS method with Proseal Laryngeal Mask Airway and NO Muscle Relaxant
干预措施: Proseal LMA (Device)
Proseal LMA & No Muscle Relaxant
Children undergoing laparoscopic inguinal hernia repair using PIRS method with Proseal Laryngeal Mask Airway and NO Muscle Relaxant
干预措施: No Muscle Relaxant (Other)
Proseal LMA & Subparalytic Muscle Relaxant
Children undergoing laparoscopic inguinal hernia repair using PIRS method with Proseal Laryngeal Mask Airway and subparalytic dose Muscle Relaxant
干预措施: Proseal LMA (Device)
Proseal LMA & Subparalytic Muscle Relaxant
Children undergoing laparoscopic inguinal hernia repair using PIRS method with Proseal Laryngeal Mask Airway and subparalytic dose Muscle Relaxant
干预措施: Rocuronium (Drug)
结局指标
主要结局
Intraabdominal Pressure
时间窗: Intraoperative continuous monitoring
Surgery Time
时间窗: Intraoperative
Time from skin prep to last suture
Time Under Anesthesia
时间窗: Intraoperative
Time from induction to moderate Alderete score of 9 or above
Intragastric Pressure
时间窗: Intraoperative continuous monitoring
次要结局
未报告次要终点
研究者
Asst. Prof. Serkan Tulgar, M.D.
Principle Investigator
Maltepe University