Rapid Sequence Intubation With Magnesium-rocuronium Compared With Succinylcholine - A Randomised Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Intubation score
研究概览
简要总结
Magnesium accelerates the reaction of rocuronium, a neuromuscular blocker used for muscle relaxation to ease the intubation during anaesthesia.
Succinylcholine is a very fast reacting neuromuscular blocker. It is often used in emergency procedures, when rapid intubation is necessary.
We want to now if a perfusion of magnesium before anaesthesia accelerates to such an extent the reaction of rocuronium that intubation conditions are comparable or even better than with succinylcholine alone (prior perfusion of saline=placebo)
详细描述
Rapid sequence intubation (RSI) is the preferred method of endotracheal intubation in the emergency setting. The aim of RSI is to achieve rapid unconsciousness and complete neuromuscular blockade which facilitates endotracheal intubation. RSI is of particular importance in unfastened patients who are at risk of regurgitation and subsequent aspiration of stomach contents into the lungs during induction of anaesthesia.
Still today, succinylcholine is the neuromuscular blocking agent of choice for RSI. However, unfortunately in 60 at 80% the intubations conditions not are excellent and there are contraindications for the usage of succinylcholine and numerous side effects. Thus there is a need for alternative techniques that allow for rapid, high-quality and safe intubation conditions. Magnesium has an impact on neuromuscular transmission; it reduces the amount of acetylcholine that is released at the motor nerve terminal.
It has been shown that an IV infusion of magnesium sulphate prior to a standard intubation dose of rocuronium enhanced the speed of onset of the neuromuscular block compared with rocuronium alone by about 35% and there was much less variability in onset times. This makes the combination magnesium-rocuronium a potentially interesting alternative to succinylcholine for RSI.
The investigators objective is to compare in surgical patients during a standardized RSI procedure intubation conditions with rocuronium 0.6 mg kg-1 after pre-treatment with intravenous MgSO4 60 mg kg-1 (experimental intervention) with succinylcholine 1 mg kg-1 (control intervention) and to quantify any minor or major adverse event.
The investigators primary hypothesis is that with rocuronium 0.6 mg kg-1, after pre-treatment with MgSO4 60 mg kg-1, the rate of excellent intubation conditions will be higher (80%) compared with succinylcholine 1 mg kg-1 (60%).
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
- •Adult, age ≥18 to 65 years, male or female.
- •American Society of Anaesthesiology [ASA] status I or II.
- •Patient is able to read and understand the information sheet and to sign and date the consent form.
- •Patient scheduled of elective surgery lasting ≥60 minutes.
- •If the patient is female and of childbearing potential, she must have a negative pregnancy test.
排除标准
- •A history of allergy or hypersensitivity to rocuronium, succinylcholine or magnesium sulphate
- •Neuromuscular disease
- •History of malignant hyperthermia
- •Preoperative medications known to influence neuromuscular function (for instance, certain antibiotics [aminoglycosides], anticonvulsants [phenytoine], or IV lidocaine)
- •Electrolyte abnormalities* (for instance, hypermagnesemia or hyperkalemia)
- •Hepatic dysfunction* (i.e. bilirubin >1.5 x upper limit normal (ULN), alanine aminotransferase (ALT) >2.5 x ULN, aspartate aminotransferase (AST) >2.5 x ULN)
- •Renal insufficiency* (i.e. creatinine >1.5 x ULN, creatinine clearance < 60 ml min-1 1.73 m-2, estimated by the formula by Cockcroft-Gault)).
- •Atrioventricular heart block
- •Patients with magnesium treatment
- •Patients with a body mass index <19 or >28 kg m2
- •Pregnant or breastfeeding women
- •Expected difficult intubation or mask ventilation.
- •Patient having participated in any clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial.
研究组 & 干预措施
Magnesium perfusion - Rocuronium
60 mg/kg of magnesium perfusion over 15 minutes before Anaesthesia. After Anaesthesia induction 0.6 mg/kg of Rocuronium intravenously
干预措施: Magnesium perfusion (Drug)
Magnesium perfusion - Rocuronium
60 mg/kg of magnesium perfusion over 15 minutes before Anaesthesia. After Anaesthesia induction 0.6 mg/kg of Rocuronium intravenously
干预措施: Rocuronium (Drug)
Placebo perfusion - Succinylcholine
1ml/kg of saline (placebo) over 15 minutes before Anaesthesia. After Anaesthesia induction 1 mg/kg of Succinylcholine intravenously
干预措施: Placebo perfusion (Drug)
Placebo perfusion - Succinylcholine
1ml/kg of saline (placebo) over 15 minutes before Anaesthesia. After Anaesthesia induction 1 mg/kg of Succinylcholine intravenously
干预措施: Succinylcholine (Drug)
结局指标
主要结局
Intubation score
时间窗: Patient will be followed over 24 hours
Intubation conditions will be evaluated using a published score that takes into account ease of laryngoscopy (easy, fair, difficult), vocal cords position (abducted, intermediate/moving, closed) and presence of diaphragmatic movement or coughing while inserting the tube (none, slight, vigorous/sustained). The final score summarises intubation conditions as excellent (all qualities are excellent), good (all qualities are either excellent or good), or poor (presence of a single quality listed under "poor").
次要结局
- Signs of histamine release(From start of anesthesia induction upto 30 minutes after intubation)
- awareness and muscle pain(24 hour follow up)
研究者
Christoph Czarnetzki
Responsable Investigator
University Hospital, Geneva