The Effect of Magnesium Sulphate on the Time Course of Rocuronium Induced Neuromuscular Block - A Randomised Electrophysiology Study
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
- To study whether a pre-treatment with MgSO4, 60 mg kg-1, administered as an intravenous infusion 15 minutes prior to induction enhances the speed of onset of a standard intubation dose of rocuronium
研究概览
简要总结
The aim of this study is to investigate whether an optimized pre-treatment with intravenous magnesium enhances the speed of onset of a standard intubation dose of rocuronium.
详细描述
In a previous study pre-treatment with intravenous MgSO4 60 mg kg-1 was not shown to have any impact on the onset of action of rocuronium [Kussmann et al, 1997]. Yet, in that study, MgSO4 was injected as a bolus after induction of anaesthesia, one minute only before the injection of the neuromuscular blocking agent. We suppose that magnesium needs some time to penetrate the neuromuscular endplate and to shift the Mg/Ca ratio in favor of magnesium. Thus, the particular design of the previous study may explain why magnesium had no scope to enhance the speed of onset of action of rocuronium.
The aim of our study is to investigate whether an optimised pre-treatment with magnesium (short infusion rather than bolus injection; reasonable delay between administration of magnesium and subsequent injection of the neuromuscular blocking agent) enhances the speed of onset of a standard intubation dose of rocuronium.
- Preanaesthetic preparation
- Solid food and liquid intake will not be allowed for a minimum of six hours before induction
- Patients will be premedicated with 7.5 mg oral midazolam 45 min prior to induction
- Standard monitoring will consist of: ECG, SaO2, ETCO2, non-invasive blood pressure, rectal or oesophageal T°
- Study drug administration
- Intravenous infusion of the study solution, 1 ml per kg bodyweight, corresponding to MgSO4 60 mg kg-1 in the magnesium group. The infusion will be given with an Infusomat during 15 minutes.
- Induction and maintenance of anaesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anaesthesiology (ASA) status I or II
- •Adults, aged 18 years to 60 years
- •Scheduled for elective surgery lasting longer than 120 min without need for continuous curarisation
排除标准
- •A history of allergy or hypersensitivity to rocuronium
- •Neuromuscular disease
- •Preoperative medications known to influence neuromuscular function (for instance, certain antibiotics and anticonvulsants)
- •Electrolyte abnormalities
- •Hepatic or renal insufficiency
- •Patients with a body mass index <19 or >28 kg m2
- •Pregnant or breastfeeding women
- •Expected difficult intubation or mask ventilation
研究组 & 干预措施
Physiologic saline
干预措施: Physiologic saline (Drug)
Magnesium sulphate
干预措施: Magnesium sulphate (Drug)
结局指标
主要结局
To study whether a pre-treatment with MgSO4, 60 mg kg-1, administered as an intravenous infusion 15 minutes prior to induction enhances the speed of onset of a standard intubation dose of rocuronium
时间窗: 1 to 5 minutes
Onset time ist the time in seconds from start of injection of rocuronium until 95% depression of the first twitch (T1) of the Train of four (TOF)
次要结局
- To study whether, and to what extent, pre-treatment with MgSO4 prolongs recovery characteristics of the neuromuscular block that is induced by rocuronium(minutes to hours)
- To study possible haemodynamic effects of pre-treatment with MgSO4.(hours)
研究者
Christoph Czarnetzki
Study Leader
University Hospital, Geneva