Rapid Sequence Intubation With Magnesium-rocuronium Compared With Succinylcholine - A Randomised Clinical Study
Information source: University Hospital, Geneva
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intubation Conditions
Intervention: Magnesium perfusion (Drug); Rocuronium (Drug); Placebo perfusion (Drug); Succinylcholine (Drug)
Phase: Phase 2
Sponsored by: University Hospital, Geneva
Official(s) and/or principal investigator(s):
Christoph Czarnetzki, MD, PD, Principal Investigator, Affiliation: University hospitals of Geneva
Martin R Tramèr, MD, PhD, Study Chair, Affiliation: University hospitals of Geneva
Christian Kern, MD, Prof, Principal Investigator, Affiliation: University Hospitals of Lausanne, Switzerland
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)
Official title: Rapid Sequence Intubation With Magnesium-rocuronium Compared With Succinylcholine - A Randomised Clinical Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Intubation score
Signs of histamine release
awareness and muscle pain
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
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.
Minimum age: 18 Years.
Maximum age: 65 Years.
- 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
- Patient scheduled of elective surgery lasting ≥60 minutes.
- If the patient is female and of childbearing potential, she must have a negative
- A history of allergy or hypersensitivity to rocuronium, succinylcholine or magnesium
- 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.
Locations and Contacts
University Hospital of Geneva, Anesthesia Department, Geneva, Canton of Geneva 1211, Switzerland
Division of Anaesthesiology, University Hospital of Lausanne (CHUV), Lausanne, Vaud 1011, Switzerland
Starting date: September 2012
Last updated: July 17, 2015