Effect of Magnesium Sulfate on the Reversal of Neuromuscular Blockade With Sugammadex: a Prospective, Randomized Double-blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate
研究概览
简要总结
The aim of this study is to determine the recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate.
详细描述
Sugammadex is a novel neuromuscular blocking reversal agent. Its mechanism of action is the encapsulation of rocuronium and vecuronium molecules. Numerous studies show a potential role of magnesium in reducing anesthetic requirements, sympathetic response to surgical trauma, antinociceptive action and neuroprotective effects. However, its use is limited because magnesium potentiates non-depolarizing neuromuscular blocking agents.
Primary outcome: evaluate the effect of pretreatment with magnesium sulfate on the time reversal with sugammadex (recovery of the T4/T1 ratio = 0.9) of moderate neuromuscular blockade (two answers to a train-of-four TOF) induced by rocuronium.
Secondary outcome: evaluate severe respiratory events, the incidence of residual neuromuscular blockade in the post anesthesia recovery room and postoperative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •ASA physical status 1 or 2
- •weight BMI 18.5-24.9
- •otorhinolaryngological surgeries
排除标准
- •major surgery associated with massive blood loss or fluid replacement
- •any known allergy to magnesium sulphate or any other study drugs
- •anatomical malformations expected to result in a difficult intubation;
- •known or suspected neuromuscular disorders and/or significant hepatic or renal dysfunction
- •administration of any medication known to interfere with neuromuscular blocking agents (such as anticonvulsants, aminoglycosides, calcium channel blockers and magnesium containing medications)
- •hypomagnesemia, hypermagnesemia, hypocalcemia, hypercalcemia
研究组 & 干预措施
Group Mg
Magnesium sulfate 40 mg.kg-1 + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1
干预措施: Magnesium Sulfate (Drug)
Group C
Saline 100 ml + rocuronium 0.6 mg.kg-1 + sugammadex 2 mg.kg-1
干预措施: Saline (Drug)
结局指标
主要结局
Recovery time of moderate neuromuscular blockade with sugammadex in adults pretreated with magnesium sulfate
时间窗: 3 hours
When T1 reached 25%, a single bolus dose of sugammadex 2 mg.kg-1 was administered to facilitate the recovery. The times to reach a TOF ratio of 0.9 and T1 height value were measured.
次要结局
- Assess severe respiratory events, the incidence of residual neuromuscular blockade in anesthesia recovery room(4 hours)
研究者
Paulo Alipio Germano Filho
MD, MSc
Universidade Federal do Rio de Janeiro