The Effect of Administration of Sugammadex on the Occurrence of Emergence Agitation in Pediatric Strabismus Surgery-prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- The incidence of EA in postanesthesia care unit (PACU)
研究概览
简要总结
The present trial conducted to demonstrate the administration of sugammadex as reversal of neuromuscular blockade agent reduces the incidence of emergence agitation (EA) comparing to neostigmine
详细描述
EA is one of the most common postoperative complications in after general anesthesia in pre-school aged pediatric patients. There are several causes contributed to occurrence of EA such as postoperative pain, type of surgery and surgical site, hyperthermia or hypothermia. Some researches showed that the occurrence of EA is associated with patients' anxiety and investigators of this trial inferred that patients' anxiety after general anesthesia could be related to ability to breathe. Ability to breathe is highly associated with level of residual neuromuscular blockade (NMB) after recovery from general anesthesia. Investigators evaluate the Pediatric Anesthesia Emergence Delirium (PAED) Scale to investigate whether sugammadex as reversal agents of NMB reduces the incidence of EA in pediatric patients who undergo strabismus surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled elective strabismus surgery aged 4-7 with American Society of Anesthesiologists (ASA) classification 1-3.
排除标准
- •ASA classification 3 or more
- •impaired liver function
- •impaired kidney function
- •myasthenia gravis or other neuromuscular disorders
- •history of drug allergy
- •cardiovascular disease or arrhythmia
研究组 & 干预措施
group sugammadex
If TOF count shows 0 and PTC (posttetanic count) is 1 or more, sugammadex administered dose of 4mg/kg. If TOF count shows 1 or more, 2mg/kg is administered.
干预措施: Bridion 200 MG in 2 ML Injection (Drug)
group pyridostigmine
If TOF count is 1 or less, wait until it becomes 2 and then give the patient pyridostigmine dose of 350mcg/kg. If TOF count shows 4 with fade, 350mcg/kg of pyridostigmine is administered and without fade, 200mcg/kg is administered.
干预措施: Pyridostigmine Bromide 5 MG/ML (Drug)
结局指标
主要结局
The incidence of EA in postanesthesia care unit (PACU)
时间窗: EA is assessed three times at 15-minute intervals in PACU until discharge from PACU.
EA is assessed with the PAED scale in PACU. EA is defined as the score is 10 or higher.
次要结局
未报告次要终点
研究者
Yea-Ji Lee
Assisstant professor
Konkuk University Medical Center