NCT05882643招募中不适用
The Effect of the Deep Neuromuscular Block on the Refraction and the Oculocardiac Reflex During Strabismus Surgery in Pediatric Patients - a Prospective Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- The incidence of grade 2 or greater oculocardiac reflex (induced, during strabismus surgery)
研究概览
简要总结
The purpose of this study is to determine if inducing a moderate or greater neuromuscular block (TOF count 0-3) when performing a neuromuscular block in pediatric patients aged 3 to 18 years undergoing strabismus surgery under general anesthesia can reduce the incidence of the oculocardiac reflex.
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients between the ages of 3 and 18 who are American Society of Anesthesiologists physical classification (ASA) I, II, or III scheduled for strabismus surgery under general anesthesia.
排除标准
- •Patients with underlying cardiovascular disease
- •Patients with preoperative electrocardiograms showing conduction disturbances
- •Patients with neuromuscular disease
- •Any other patient who, in the opinion of the investigator, is not a good candidate for the study.
结局指标
主要结局
The incidence of grade 2 or greater oculocardiac reflex (induced, during strabismus surgery)
时间窗: During induced oculocardiac reflex test by ophthalmologists
\> 20% reduction in heart rate induced by intentional manipulation of the extraocular rectus muscle
次要结局
- The incidence of grade 1 oculocardiac reflex (induced, during strabismus surgery)(During induced oculocardiac reflex test by ophthalmologists)
- Number of times Rescue IV Atropine has been used for oculocardiac reflex(During general anesthesia for strabismus surgery (within 2 hour))
- Results from a refraction test before strabismus surgery(Before strabismus surgery (within 12 month))
- The incidence of grade 2 or greater oculocardiac reflex (during strabismus surgery)(During general anesthesia for strabismus surgery (within 2 hour))
- Postoperative nausea/vomiting(From extubation to post-anesthesia care unit stay (within 1 hour))
- The incidence of grade 1 greater oculocardiac reflex (during strabismus surgery)(During general anesthesia for strabismus surgery (usually within 2 hour))
- Results from a refraction test at strabismus surgery(During general anesthesia for strabismus surgery (within 2 hour))
- The incidence of hypotension(During general anesthesia for strabismus surgery (within 2 hour))
研究者
Young-Eun Jang
Clinical Associate Professor
Seoul National University Hospital
研究点 (2)
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