NCT05354466Unknown不适用
Effect of Sugammadex Versus Neostigmine on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Perioperative respiratory adverse events
研究概览
简要总结
Perioperative respiratory adverse events are common in children. We aimed to evaluate the effect of sugammadex on the incidence of perioperative respiratory adverse events in pediatric patients receiving tonsillectomy
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 2-6 years who were scheduled for tonsillectomy under general anesthesia were enrolled
排除标准
- •a recent history of upper respiratory tract infection within 2 weeks of surgery
- •allergic reaction to sugammadex
- •renal failure
- •liver failure
- •arrhythmia
研究组 & 干预措施
Sugammadex as reversal agent
Experimental
干预措施: Sugammadex injection (Drug)
Neostigmine as reversal agent
Active Comparator
干预措施: Neostigmine (Drug)
结局指标
主要结局
Perioperative respiratory adverse events
时间窗: from induction of anesthesia to end of operation, about 3 hours
the incidence of overall perioperative respiratory adverse events; oxygen desaturation \< 95%, airway obstruction, laryngospasm, bronchospasm, severe coughing, or postoperative stridor
次要结局
- Nausea and vomiting(from induction of anesthesia to end of operation, about 3 hours)
- Anaphylaxis(from induction of anesthesia to end of operation, about 3 hours)
- bradycardia(from induction of anesthesia to end of operation, about 3 hours)
- Cardiac arrest(from induction of anesthesia to end of operation, about 3 hours)
- Bronchospasm(from induction of anesthesia to end of operation, about 3 hours)
- Allergic reaction(from induction of anesthesia to end of operation, about 3 hours)
研究者
Eun-hee Kim
Clinical associate professor
Seoul National University Hospital
研究点 (1)
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