the Effective Bolus Dose of Remifentanil for Laryngeal Mask Airway (LMA) Insertion in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- patients's response to the LMA insertion
研究概览
简要总结
This research attempts to find the optimum dose of remifentanil that can prevent the unnecessary responses such as coughing, gagging, and movement when LMA is inserted during sevoflurane induction in pediatric patients.
详细描述
Anaesthesia is induced by inhalation with 3% sevoflurane. A predetermined bolus dose of remifentanil is injected over 30 seconds. The LMA is attempted 60 seconds after bolus administration. The starting dose of remifentanil is 0.5μg/kg and a step size is 0.05μg/kg. If LMA insertion is successful or failed in previous patient, an decrement or increment of 0.05μg/kg remifentanil is injected to next patient, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status 1 or 2
- •undergoing short elective surgery(i.e Strabismus surgery, Entropion surgery, Inguinal hernia surgery, etc) under general anesthesia
排除标准
- •suspected difficult airways
- •respiratory disease (chronic obstructive pulmonary disease, upper respiratory infection)
- •body mass index > 30 kg/m2
- •allergies to the study drugs
- •a history of gastric reflux
研究组 & 干预措施
group R
The starting dose of remifentanil is 0.5μg/kg and a step size was 0.05μg/kg.
干预措施: Remifentanil (Drug)
结局指标
主要结局
patients's response to the LMA insertion
时间窗: 2 minutes after LMA insertion
Fail of LMA insertion is defined as body or limb movement, coughing or gagging with 2 minutes after LMA insertion, no proper jaw relaxation(difficult mouth opening), laryngospasm, bronchospasm, desaturation(SpO2\<94%)
次要结局
未报告次要终点
研究者
Sangjin Park
assistant professor
Yeungnam University College of Medicine