NCT05882643已完成不适用
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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- The incidence of grade 2 or greater oculocardiac reflex (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.
研究组 & 干预措施
block group
Experimental
- Maintaining moderate to deep neuromuscular blockade during an intraoperative period (Train-of-four 0-3, post-tetanic count > 1)
- Rocuronium (intravenous, 1.0 mg/kg)
干预措施: moderate to deep neuromuscular blockade (Other)
control group
Active Comparator
- Maintaining shallow to minimal neuromuscular blockade during an intraoperative period (Train-of-four 4, post-tetanic count < 0.9)
- Rocuronium (intravenous, 0.3 mg/kg)
干预措施: shallow to minimal neuromuscular blockade (Other)
结局指标
主要结局
The incidence of grade 2 or greater oculocardiac reflex (during strabismus surgery)
时间窗: Day 1, During general anesthesia for strabismus surgery (within 2 hours).
\> 20% reduction in heart rate during strabismus surgery
次要结局
- Results from a refraction test before strabismus surgery(Before strabismus surgery (within 12 month))
- Postoperative nausea/vomiting(From extubation to post-anesthesia care unit stay (within 1 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))
- The incidence of grade 1 oculocardiac reflex (during strabismus surgery)(Day 1, During general anesthesia for strabismus surgery (within 2 hours).)
- The incidence of grade 3 or greater oculocardiac reflex (during strabismus surgery)(During general anesthesia for strabismus surgery (usually within 2 hour))
研究者
Young-Eun Jang
Clinical Associate Professor
Seoul National University Hospital
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Neuromuscular Blockade and Surgical ConditionsMorbid ObesityNCT01564576Sheba Medical Center40
已完成
不适用
Moderate vs Deep Neuromuscular Block on Biotrauma During LaparoscopyPneumoperitoneumNCT03576118Ajou University School of Medicine74
已完成
不适用
Neuromuscular Block and Anesthetic Depth MonitoringCholecystectomy, LaparoscopicNCT02575443Seoul National University Bundang Hospital60
已完成
不适用
The BLISS 4 trialnot applicable, mostly healthy individualsNL-OMON23555MC100
已完成
不适用
Effect of deep versus moderate neuromuscular block during sevoflurane anesthesia on intraoperative surgical conditions, hemodynamics and postoperative pain in patients undergoing laparoscopic surgery for (donor) nephrectomy *anesthesie voor utrologische laparoscopische ingrepenanesthesianarcosisNL-OMON48952eids Universitair Medisch Centrum100