Optimal Effect-site Concentration of Remifentanil for Inhibiting Response to Laryngeal Mask Airway (LMA) Removal During Emergence From Sevoflurane-remifentanil Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 主要终点
- Number of Patients With Adverse Events Following LMA Removal
研究概览
简要总结
This study was designed to determine the optimal dose of remifentanil that can prevent the complications associated with the removal of LMA without delaying emergence.
详细描述
Patients were randomly assigned to one of four groups. All patients received a predetermined effect-site concentrations (Ce) of remifentanil by target-controlled infusion (TCI) according to their group assignments (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml) from 10 minutes before the end of surgery to LMA removal. Airway complications (airway obstruction, desaturation, breath holding, and coughing), nausea, and vomiting were assessed during the emergence phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 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 lower extremity surgery 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 R0.5
remifentanil Ce of 0.5 ng/ml
干预措施: Remifentanil (Drug)
group R1.0
remifentanil Ce of 1.0 ng/ml
干预措施: Remifentanil (Drug)
group R1.5
remifentanil Ce of 1.5 ng/ml
干预措施: Remifentanil (Drug)
结局指标
主要结局
Number of Patients With Adverse Events Following LMA Removal
时间窗: from the end of surgery until arrival in the post-anesthetic care unit, an expected average of 15 minutes.
All patients received a predetermined Ce of remifentanil by TCI according to their group assignments from 10 minutes before the end of surgery to LMA removal. Adverse events such as coughing, airway obstruction, breath-holding, desaturation, nausea and vomiting were evaluated from the end of surgery until arrival in the post-anesthetic care unit.
次要结局
未报告次要终点
研究者
Sangjin Park
assistant professor
Yeungnam University College of Medicine