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临床试验/NCT04013243
NCT04013243已完成不适用

Effect of Magnesium on Maintenance Dose of Rocuronium for Deep Neuromuscular Blockade During Robotic Radical Prostatectomy

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2019年4月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
rocuronium amount

研究概览

简要总结

It is well known that magnesium enhances the effect of neuromuscular blocking agents such as rocuronium. However, it is not known how much magnesium can reduce neuromuscular blocking agents in maintaining deep neuromuscular blockade. Through this study, the investigators will quantitatively analyze the rocuronium saving effect of magnesium.

详细描述

It is well known that magnesium potentiate the effect of neuromuscular blocking agents. It prolonged the duration of rocuronium and reduces the onset time of rocuronium. Magnesium acts on motor end plate, where magnesium reduces the release of prejunctional acetylcholine, thereby decreasing the muscle membrane excitability. However, the quantitative rocuronium saving effect of magnesium is not clear. This study's hypothesis is that magnesium would reduce the amount of rocuronium. And the investigators want to evaluate how much magnesium can reduce the amount of rocuronium. Secondary outcome is the effects of magnesium on recovery time, postoperative pain, nausea and vomiting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients who undergo elective robot assisted radical prostatectomy, between 20 and 80 years with a American Society of Anesthesiologists physical status classification of I or II

排除标准

  • Conduction abnormalities in preoperative EKG such as Atrioventricular block, sinus pause
  • Glomerular filtration rate <60ml/min/1.73m2
  • Allergy to rocuronium, sugammadex, magnesium
  • Medications that interfered with muscle activity
  • Neuromuscular disease
  • Hypermagnesemia

研究组 & 干预措施

Magnesium Sulfate group

Active Comparator

magnesium sulphate 50mg/kg in normal saline 50ml infusion for 10minutes for loading dose followed by 15mg/kg/hr for continuous infusion

干预措施: Magnesium Sulfate (Drug)

Placebo group

Placebo Comparator

Normal Saline 50ml infusion for loading dose followed by continuous infusion for same dose of magnesium.

干预措施: Placebo (Drug)

结局指标

主要结局

rocuronium amount

时间窗: perioperative - until 48hours

total rocuronium/weight/infusion time

次要结局

  • postoperative pain(at postoperative 30minutes, 6hours, 24hours)
  • recovery time(perioperative - until 48hours)
  • postoperative nausea and vomiting(at postoperative 30minutes, 6hours, 24hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JiWon Han

Clinical Professor

Seoul National University Bundang Hospital

研究点 (1)

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