Rapid Sequence Intubation With Magnesium-rocuronium Compared With Succinylcholine - A Randomised Clinical Study
Condition: Intubation Conditions
MeSH terms: Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      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)
    

Detailed description: 
      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%).

      This is a two centre (Division of Anaesthesiology, Geneva University Hospitals and Division
      of Anaesthesiology, University Hospital of Lausanne), stratified (male, female), randomized,
      double blinded study including 280 patients.

      The investigators will 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).

      Intubation conditions will be evaluated by the intubating anaesthesiologist following
      predefined criteria. The intubating anesthetist will not be present at study drug
      administration to guarantee blinding. Only two intubating anaesthetists will be identified
      per participating centre.

      Rapid sequence intubation is a cornerstone of daily anaesthetic practice and succinylcholine
      is still the most frequently used neuromuscular agent in this context. In some patients,
      succinylcholine is contraindicated and therefore alternatives to this very fast reacting
      neuromuscular blocker are needed. If the investigators show that the investigators proposed
      magnesium-rocuronium regimen provides better intubation conditions as succinylcholine, the
      investigators study is likely to have an important impact on daily clinical practice.
    

Intervention name(s): Magnesium perfusion; Rocuronium; Placebo perfusion; Succinylcholine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The patient receives during 15 minutes a perfusion of 60mg/kg of Magnesium sulphate before induction of anaesthesia.; Immediately after anaesthesia induction and loss of consciousness 0,6 mg/kg of rocuronium will be injected; The patient receives during 15 minutes a perfusion of 1 ml/kg of saline before induction of anaesthesia; Immediately after anaesthesia induction at loss of consciousness 1 mg/kg of succinylcholine will be injected
Other intervention name(s): Magnesium; Zemuron; Saline; Anectine
Intervention MeSH terms: Rocuronium; Succinylcholine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rocuronium; succinylcholine; magnesiumsulphate; intubation conditions