Criteria Based Discharge in Ambulatory Surgery in Children Undergoing Opioid Versus Opioid Free Anesthesia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Discharge times from the hospital
研究概览
简要总结
The investigators intend to study the safety and effectiveness of opioid free anesthesia compared to opioid anesthesia in ambulatory surgery in children, regarding postoperative pain, hemodynamic stability, agitation and discharge times. Quality of postanesthetic care was estimated in a 24h follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children,
- •American Society Anesthesia I, II,
- •ambulatory surgery
排除标准
- •Allergy to anesthetic and analgesic drugs,
- •history of neuromuscular,
- •renal, neurological, hepatic disease,
- •craniofacial anomalies,
- •Obstructive Sleep Apnea,
- •cardiopulmonary diseases
研究组 & 干预措施
opiod free general anesthesia
In group A opioid free anesthesia is administered. Anesthesia and analgesia were achieved with ketamine(1mg/kg, bolus), dexmedetomidine(1mcg/kg, over 10 minutes), local anesthetic(ropivacaine 2mg/kg 0.75% wound infiltration), paracetamol(15mg/kg), non steroid analgesics(diclofenac 1mg/kg). Anesthesia induction with ketamine(1mg/kg), propofol 1% 2-3mg/kg, rocuronium 1mg/kg. Anesthesia maintenance with propofol 1% 10mg/kg/hour. Reversal of rocuronium with sugammadex 2mg/kg.
干预措施: Ketamine, dexmedetomidine (Drug)
opioid based general anesthesia
In group B opioid based anesthesia is administered.Anesthesia and analgesia were achieved with remifentanil(0.3mcg/kg/minute), local anesthetic(ropivacaine 2mg/kg 0.75% wound infiltration), paracetamol(15mg/kg), non steroid analgesics(diclofenac 1mg/kg).Anesthesia induction with propofol 1% 2-3mg/kg,fentanyl(2mcg/kg), rocuronium 1mg/kg. Anesthesia maintenance with propofol 1% 10mg/kg/hour. Reversal of rocuronium with sugammadex 2mg/kg.
干预措施: fentanyl, remifentanil (Drug)
结局指标
主要结局
Discharge times from the hospital
时间窗: 4 hours
Comparison of the discharge times from the hospital between opioid free and opioid based anesthesia using Discharge criteria based on physiological scoring system, evaluating respiration, circulation, level of consciousness, postoperative pain, postoperative nausea and vomiting and surgical site. A score 12 or more allows patient to leave safely from the hospital.
Severity of postoperative pain
时间窗: 24 hours
Comparison of the severity of postoperative pain between opioid free and opioid based anesthesia using the Face, Legs, Activity, Cry, Consolability scale or FLACC scale for children between the ages of 3 years and 7 years. The scale has five criteria, which are each assigned a score of 0, 1 or 2.The scale is scored in a range of 0-10 with 0 representing no pain.
次要结局
- Cost effect(24 hours)
- Extubation time(30 minutes)
- Discharge time from PACU(60 minutes)
研究者
Adelais Tsiotou
Consultant of Anesthesiology Department
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"