Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery: Comparison of Neostigmine and Sugammadex
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- the incidence of postoperative residual curarization
研究概览
简要总结
Compare the reversal effect of neostigmine and sugammadex using quantitative neuromuscular monitoring
详细描述
At the end of surgery, decide the dosage of reversal referring to quantitative neuromuscular monitoring value (TOF). After the administration of reversal, the anesthesiologist who are going to manage the participant should not check the quantitative neuromuscular monitoring and determine the timing of extubation only with his (or her) judgement. After entering post-anaesthesia care unit (PACU) measure the TOF value and check the incidence of TOF ratio > 0.9 between the neostigmine group and sugammadex group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged over 18 years, planned to undergoing elective laparoscopic surgery under general anesthesia
排除标准
- •Obesity BMI over 30 kg/m2
- •Impairment of renal or/and liver function
- •Allergy to rocuronium, sugammadex
- •(Familial) history of malignant hyperthermia
- •Taking medicines which is affecting neuromuscular function
研究组 & 干预措施
Neostigmine
At the end of surgery, administrating neostigmine to participants according to the protocol below:
when train-of-four (TOF) 2-3, administrating neostigmine 50mcg/kg when TOF 4 with fade, administrating neostigmine 40mcg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg
干预措施: Neostigmine (Drug)
Sugammadex
At the end of surgery, administrating sugammadex to participants according to the protocol below:
when TOF=0 and post-tetanic count (PTC)=1 or more, administrating sugammadex 4mg/kg when TOF=1 or more, administrating sugammadex 2mg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg
干预措施: Sugammadex (Drug)
结局指标
主要结局
the incidence of postoperative residual curarization
时间窗: Immediately after entering PACU
definition of postoperative residual curarization: TOF ration is 0.9 or over 0.9
次要结局
未报告次要终点
研究者
LEE YEA JI
clinical professor of department of anesthesiology and pain medicine
Seoul National University Bundang Hospital