NCT03060707Unknown4 期
Comparison of Hourly Rocuronium Consumption Using Continuous Infusion Versus Intermittent Bolus Injection: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Rocuronium dose per kilogram per hour
研究概览
简要总结
The research is to find out whether continuous infusion of rocuronium requires more or less amount of rocuronium, per kilogram and per hour, than bolus administered rocuronium during noncardiac surgery.
详细描述
comparing the total dose of rocuronium between continuous infusion and intermittent injection
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged between 2 and 12, undergoing elective noncardiac surgery which requires general anesthesia but does not require intense block, and estimated time of surgery is between 2 and 5 hours
排除标准
- •ASA class 3-6
- •BMI >= 30
- •Previous history of hepatic failure, renal failure or neuromuscular disease
- •Patients taking medicine which interacts with rocuronium bromide, before or during surgery: aminoglycosides, lincosamides, acylamino-penicillin antibiotics, tetracyclines, metronidazole (high dose), diuretics, MAO inhibitors, calcium channel blockers, corticosteroids, phenytoin, carbamazepine, or norepinephrine
- •Previous history of allergic reaction (including anaphylactic reaction) and/or malignant hyperthermia during general anesthesia
- •Patients taking medicines which contains magnesium
研究组 & 干预措施
Continuous infusion
Experimental
The group of participants who are designated to receive continuously infused rocuronium.
干预措施: Rocuronium Bromide (Drug)
Bolus administration
Active Comparator
The group of participants who are designated to receive bolus administered rocuronium.
干预措施: Rocuronium Bromide (Drug)
结局指标
主要结局
Rocuronium dose per kilogram per hour
时间窗: end of the surgery
Total dose of rocuronium injected during surgery, divided by patient body weight and anesthesia time.
次要结局
- Desaturation event(Right after the patient is transferred to the ward, from PACU (1 day))
- Surgical rating scale(end of the surgery)
研究者
Hee-Soo Kim
Prof.
Seoul National University Hospital
研究点 (1)
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