Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery on Peri-operative Outcomes and Neurocognitive Development in Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Deferred Imitation scores at 6 months
研究概览
简要总结
This is a prospective randomized controlled trial comparing dexmedetomidine sedation with caudal anaesthesia, and general sevoflurane anaesthesia with caudal anaesthesia for inguinal herniotomies in neonates and infants below 3 months of age.
The investigators will compare the efficacy and adverse events associated with each of these techniques and neurodevelopmental outcomes of the infants in each group at 6 months and 2 years of age.
详细描述
Several epidemiologic studies have suggested that children exposed to general anaesthesia (GA) in early childhood may be at increased risk of subsequent learning disabilities and behavioural problems. Animal studies have shown that exposure to GA agents during critical neuro-developmental windows induces neuronal apoptosis. All commonly used anaesthetic agents induce neurotoxicity with the exception of dexmedetomidine, a highly specific alpha-2 agonist which has been shown to be neuroprotective.
GA is the current standard of care for inguinal hernia repair in infants at KKH. The investigators recently demonstrated that dexmedetomidine sedation with caudal block is a feasible alternative for inguinal hernia repair in infants below 3 months of age. This prospective randomized controlled trial will compare the early and long-term outcomes of infants following inguinal hernia surgery using dexmedetomidine sedation with caudal block versus GA with caudal block.
This study aims:
- To compare the neurodevelopment at 6 months and 2years, of infants randomized to dexmedetomidine sedation with caudal block with those randomized to GA with caudal block for inguinal hernia surgery before 3 months of age.
- To compare the efficacy of dexmedetomidine sedation with caudal block versus GA with caudal block for inguinal hernia surgery, in terms of duration of anaesthesia, duration of surgery and surgeon's satisfaction with intraoperative conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 34 Weeks 至 54 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants below 3 months of age ( corrected age 54 weeks) presenting for elective inguinal hernia repair in KKH.
排除标准
- •History of prematurity younger than 28 weeks gestation,
- •Requirement for CPAP greater than 6 cmH20 at time of surgery
- •Significant cardiac pathology or cardiac conduction defects
- •Unusually large hernia sacs
- •Any contraindication for caudal anesthesia
- •Surgeon refusal on account of anticipated prolonged or difficult surgery.
研究组 & 干预措施
Dex Group
Intravenous dexmedetomidine sedation prior to single shot caudal anaesthesia and maintenance infusion of dexmedetomidine during bilateral inguinal hernia surgery.
干预措施: Dexmedetomidine sedation (Drug)
Dex Group
Intravenous dexmedetomidine sedation prior to single shot caudal anaesthesia and maintenance infusion of dexmedetomidine during bilateral inguinal hernia surgery.
干预措施: Caudal anaesthesia (Procedure)
Dex Group
Intravenous dexmedetomidine sedation prior to single shot caudal anaesthesia and maintenance infusion of dexmedetomidine during bilateral inguinal hernia surgery.
干预措施: Inguinal hernia surgery (Procedure)
GA Group
General sevoflurane anaesthesia with endotracheal intubation and single shot caudal anaesthesia for inguinal hernia surgery. This is currently the standard anaesthetic technique for bilateral inguinal hernia surgery in neonates and infants in KKH.
干预措施: General sevoflurane anaesthesia (Drug)
GA Group
General sevoflurane anaesthesia with endotracheal intubation and single shot caudal anaesthesia for inguinal hernia surgery. This is currently the standard anaesthetic technique for bilateral inguinal hernia surgery in neonates and infants in KKH.
干预措施: Caudal anaesthesia (Procedure)
GA Group
General sevoflurane anaesthesia with endotracheal intubation and single shot caudal anaesthesia for inguinal hernia surgery. This is currently the standard anaesthetic technique for bilateral inguinal hernia surgery in neonates and infants in KKH.
干预措施: Inguinal hernia surgery (Procedure)
结局指标
主要结局
Deferred Imitation scores at 6 months
时间窗: 6 months
Deferred imitation, test of declarative memory. Infants are assessed when first shown the "target" actions (DF1) and again on how well they reproduce the actions (DF2).
次要结局
- Bayley scores at 2 years(2 years)
