Comparison of the Clinical Performances of Flexible Laryngeal Mask Airway in Pediatric Patients Under General Anesthesia With or Without Muscle Relaxant: a Randomized Controlled Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Oropharyngeal leak pressure (OLP)
研究概览
简要总结
The use of laryngeal mask airway (LMA) is increasing in pediatric anesthesia because it provides lesser direct mechanical stimulation of the airway due to being placed above the larynx. However, LMA insertion can be more difficult in children than in adults due to their unique characteristics of pediatric airway. Neuromuscular blocking agents, so-called, muscle relaxants have long been used to facilitate insertion of airway devices. But there are pros and cons for the efficacy of muscle relaxants in LMA insertion, and most studies were investigated in adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 2 and 7 years of American Society of Anesthesiologists physical status (ASA PS) I or II who are planned to receive ophthalmic surgery under general anesthesia
排除标准
- •Refusal of consent
- •Present URI or other respiratory symptoms
- •Oro or facial anomaly
- •Poor dental condition
- •who cannot open their mouth or limited mouth opening
- •when the tracheal intubation is definitely needed
研究组 & 干预措施
MR group
When the patients asleep, 0.3 mg/kg rocuronium is administered.
干预措施: rocuronium (Drug)
NMR group
When the patients asleep, 0.3 mg/kg saline is administered.
干预措施: saline (Drug)
结局指标
主要结局
Oropharyngeal leak pressure (OLP)
时间窗: During 1 min after successful LMA intubation
It was determined by the method describe by Lopez-Gil and colleagues. Briefly, it was measured by closing the expiratory valve of the circle system at a fixed gas flow of 3l/min, recording the airway pressure at which audible leak sound was heard.
次要结局
- Intubation time(During 5-10 min after inhalation of sevoflurane)
- Ease of intubation/mask bagging(During 5-10 min after inhalation of sevoflurane)
- Fiberoptic view of LMA(During 5min after successful LMA insertion)
- Mean blood pressure(During 5-10 min after inhalation of sevoflurane)
- Heart rate(During 5-10 min after inhalation of sevoflurane)
- Watcha scale every 10 min from time to PACU admission to discharge(During 60 minutes after PACU admission)
- FLACC score on initial, 10, 20, and 30 min(During 60 minutes after PACU admission)
- Eye opening time(During 1 hour after operation)
- Extubation time(During 1 hour after operation)
- Peak inspiratory pressure before and after the surgery(During 4 hour after anesthetic inhalation)
- Tidal volume ratio before and after the surgery(During 4 hour after anesthetic inhalation)
- Respiratory adverse events(During 1 hour after operation)
- Postoperative complications(During 1 hour after operation)
研究者
Eugene Kim
Assistant professor
Daegu Catholic University Medical Center