Effects of Magnesium Sulphate on the Pharmacodynamics of Rocuronium in Patients 60 Years or Older: Randomised and Double-Blind Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Total recovery time of neuromuscular block (DurTOF0.9)
研究概览
简要总结
The purpose of this study is to evaluate the effects of MgSO4 administration on the pharmacodynamics of rocuronium in patients with 60 or more years of age.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60 years or older
- •ASA physical status I-III
- •Scheduled for elective oncologic head and neck surgery
排除标准
- •Severe renal insufficiency (calculated creatinine clearance < 30 ml/min)
- •Pre-operatory serum magnesium values > 2.5 mEq/l
- •Patients receiving medications known to affect neuromuscular function (furosemide, aminoglycoside, anticonvulsivants, calcio channel blocker, litium, azatioprine, cyclofosfamide)
研究组 & 干预措施
Magnesium sulfate group
In the magnesium group, patients received MgSO4 30 mg/kg in 0.9% physiological saline (total volume 100 ml) intravenously, for 10 min, and then continuous intravenous infusion of MgSO4 at a rate of 1 g/h during the surgical procedure until the maximum of 3 h.
干预措施: Magnesium Sulfate (Drug)
Control group
Controls received 100 ml of 0.9% physiological saline, for 10 min, and then continuous intravenous infusion of saline at a rate of 33 ml/h during the surgical procedure until the maximum of 3 h.
干预措施: Placebo (Drug)
结局指标
主要结局
Total recovery time of neuromuscular block (DurTOF0.9)
时间窗: Within the surgical procedure
Time from the start of injection of rocuronium until TOF ratio 0.9
次要结局
- Onset time(Within the surgical procedure)
- Recovery index (Dur25-75%)(Within the surgical procedure)
- Recovery time (Dur25%TOF0.9)(Within the surgical procedure)
- Clinical duration (Dur25%)(Within the surgical procedure)
研究者
Pedro Rotava
Mr
Instituto Nacional de Cancer, Brazil