An Open Label Pilot Study of Feasibility of a Dexmedetomidine-Remifentanil-Caudal Anaesthetic for Infant Lower Abdominal/Lower Extremity Surgery: The TREX Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Number of participants who need for intervention for light anaesthesia
研究概览
简要总结
Animal studies suggest general anaesthetics harm the developing brain. It is unclear if these findings are relevant to humans but the issue has become a major concern. Recent data have found that monkeys exposed to anaesthesia as infants grow up to have slower learning than those not exposed.
The aim of the TREX pilot study is to determine the feasibility of an alternative anaesthetic regimen for lower abdominal/lower extremity surgery in infants 1-12 months of age.
详细描述
Animal studies suggest general anaesthetics harm the developing brain. It is unclear if these findings are relevant to humans but the issue has become a major concern. Recent data have found that monkeys exposed to anaesthesia as infants grow up to have slower learning than those not exposed.
The aim of the TREX pilot study is to determine the feasibility of an alternative anaesthetic regimen for lower abdominal/lower extremity surgery in infants 1-12 months of age.
An alternative anaesthetic regimen comprises a dexmedetomidine-based anaesthetic, augmented with an opioid (remifentanil) and a regional nerve block (such as a caudal).
This open label prospective single arm pilot study will enrol 60 infants aged 1-12 months scheduled for lower limb, urologic, or lower abdominal surgery. After sevoflurane induction, the infants will have a caudal anaesthetic and intravenous dexmedetomidine and remifentanil.
The outcome will be need for intervention for light anaesthesia, intervention for haemodynamic changes and rate of abandoning the protocol. Recovery times will also be recorded.
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 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged 1 to 12 months (corrected age)
- •ASA I or II
- •Infants undergoing lower abdominal/lower extremity surgery anticipated to be > 120 minutes in duration
- •Surgery requires caudal regional nerve block
排除标准
- •ASA III or higher
- •Any contraindication to caudal analgesia
- •Any contraindication to an inhalational induction with sevoflurane
- •Allergies to any medication in study protocol
- •Planned admission to an ICU postoperatively (except level II or III neonatal ICU)
- •Planned tracheal intubation postoperatively
- •Mechanical ventilation postoperatively
研究组 & 干预措施
Active open label single arm
Dexmedetomidine- remifentanil- caudal based anaesthetic for lower abdominal/lower extremity surgery.
Dexmedetomidine (Precedex): loading dose: 1 mcg/kg over 10 minutes. Infusion: Start 1 mcg/kg/hr; titrate up or down within 50% of starting doses as needed
Remifentanil (Ultiva): loading dose: 1 mcg/kg over 1-2 minutes. Infusion: Start at 0.2 mcg/kg/min. Titrate up or down (max 0.5 mcg/kg/min) as needed
Caudal- Bupivacaine (Marcaine) 0.175%-0.25% or Ropivacaine (Naropin) 0.2% with dose at discretion of anaesthetist
干预措施: Dexmedetomidine (Drug)
Active open label single arm
Dexmedetomidine- remifentanil- caudal based anaesthetic for lower abdominal/lower extremity surgery.
Dexmedetomidine (Precedex): loading dose: 1 mcg/kg over 10 minutes. Infusion: Start 1 mcg/kg/hr; titrate up or down within 50% of starting doses as needed
Remifentanil (Ultiva): loading dose: 1 mcg/kg over 1-2 minutes. Infusion: Start at 0.2 mcg/kg/min. Titrate up or down (max 0.5 mcg/kg/min) as needed
Caudal- Bupivacaine (Marcaine) 0.175%-0.25% or Ropivacaine (Naropin) 0.2% with dose at discretion of anaesthetist
干预措施: Remifentanil (Drug)
Active open label single arm
Dexmedetomidine- remifentanil- caudal based anaesthetic for lower abdominal/lower extremity surgery.
Dexmedetomidine (Precedex): loading dose: 1 mcg/kg over 10 minutes. Infusion: Start 1 mcg/kg/hr; titrate up or down within 50% of starting doses as needed
Remifentanil (Ultiva): loading dose: 1 mcg/kg over 1-2 minutes. Infusion: Start at 0.2 mcg/kg/min. Titrate up or down (max 0.5 mcg/kg/min) as needed
Caudal- Bupivacaine (Marcaine) 0.175%-0.25% or Ropivacaine (Naropin) 0.2% with dose at discretion of anaesthetist
干预措施: Bupivacaine (Drug)
Active open label single arm
Dexmedetomidine- remifentanil- caudal based anaesthetic for lower abdominal/lower extremity surgery.
Dexmedetomidine (Precedex): loading dose: 1 mcg/kg over 10 minutes. Infusion: Start 1 mcg/kg/hr; titrate up or down within 50% of starting doses as needed
Remifentanil (Ultiva): loading dose: 1 mcg/kg over 1-2 minutes. Infusion: Start at 0.2 mcg/kg/min. Titrate up or down (max 0.5 mcg/kg/min) as needed
Caudal- Bupivacaine (Marcaine) 0.175%-0.25% or Ropivacaine (Naropin) 0.2% with dose at discretion of anaesthetist
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Number of participants who need for intervention for light anaesthesia
时间窗: 120 minutes (duration of surgery)
Rescue treatment for light anaesthesia will be given if hypertension MAP \> 80 mmHg (confirmed with repeated measure) and/or patient movement.
次要结局
- Number of participants who have pain after anaesthesia(End of surgery until discharge from PACU ( average 1-4 hours))
- Number of participants who have respiratory complications(Start of anaesthesia until discharge from PACU (average 1-4 hours))
- Number of participants who require rescue analgesia in PACU(End of surgery until discharge from PACU (average 1-4 hours))
- Number of participants who need for intervention for haemodynamic changes(120 minutes (duration of surgery))
- Time to recovery after anaesthesia(Time from last dressing to: eye opening, removal of airway device, first feed, and a modified Aldrete Score of 9-10 (average 30 minutes-4 hours))