Rapid Sequence Intubation With Magnesium-rocuronium Compared With Succinylcholine - A Randomised Clinical Study (MagInRoc)

This study is currently recruiting participants.
Verified September 2012 by University Hospital, Geneva
Sponsor:
Collaborator:
University of Lausanne Hospitals
Information provided by (Responsible Party):
Christoph Czarnetzki, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01571908
First received: April 3, 2012
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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 standardised 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), randomised, double blinded study including 280 patients.

The investigators will compare in surgical patients during a standardised 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 anesthesiologist following predefined criterias. The intubating anaethesist will not be present at study drug administration to guaranty 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.


Condition Intervention Phase
Intubation Condtions
Drug: Magnésium sulphate
Drug: Curarisation with rocuronium
Drug: Perfusion of Placebo
Drug: Succinylcholine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rapid Sequence Intubation With Magnesium-rocuronium Compared With Succinylcholine - A Randomised Clinical Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Intubation score [ Time Frame: Patient will be followed over 24 hours ] [ Designated as safety issue: No ]
    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").


Secondary Outcome Measures:
  • Signs of histamine release [ Time Frame: From start of anesthesia induction upto 30 minutes after intubation ] [ Designated as safety issue: Yes ]
    Immediately after intubation, patients will be evaluated for signs of histamine release (bronchospasm, erythema, oedema).

  • awareness and muscle pain [ Time Frame: 24 hour follow up ] [ Designated as safety issue: Yes ]
    The day after surgery, patients will be visited and will be screened for awareness and muscle pain.


Estimated Enrollment: 280
Study Start Date: September 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnesium-Rocuronium arm Drug: Magnésium sulphate
The patient receives during 15 minutes a perfusion of 60mg/kg of Magnesium sulphate before induction of anaesthesia
Drug: Curarisation with rocuronium
Immediately after anaesthesia induction at loss of consciouness 0,6 mg/kg of rocuronium will be injected
Active Comparator: Succinylcholine Arm Drug: Perfusion of Placebo
The patient receives during 15 minutes a perfusion of 1 ml/kg of NaCl 0.9 % before induction of anaesthesia
Drug: Succinylcholine
Immediately after anaesthesia induction at loss of consciouness 1 mg/kg of succinylcholine will be injected

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 clearence < 60 ml min-1 1.73 m-2, estimated by the formula by Cockroft & 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571908

Contacts
Contact: Christoph A Czarnetzki, MD, MBA 0041223723311 christoph.czarnetzki@hcuge.ch
Contact: Martin R Tramèr, MD, PhD 0041223723311 martin.tramer@hcuge.ch

Locations
Switzerland
University Hospital of Geneva, Anesthesia Department Recruiting
Geneva, Canton of Geneva, Switzerland, 1211
Contact: Christoph A Czarnetzki, MD, MBA     0041223723311     christoph.czarnetzki@hcuge.ch    
Principal Investigator: Christoph A Czarnetzki, MD, MBA            
Sub-Investigator: Christopher Lysakowski, MD            
Division of Anaesthesiology, University Hospital of Lausanne (CHUV) Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Sylvain Ganer, MD     004121 314 11 11     sylvain.gander@chuv.ch    
Contact: Christian Kern, MD, Prof     004121 314 11 11     christian.kern@chuv.ch    
Principal Investigator: Christian Kern, MD, Prof            
Sub-Investigator: Sylvain Gander, MD            
Sponsors and Collaborators
University Hospital, Geneva
University of Lausanne Hospitals
Investigators
Principal Investigator: Christoph Czarnetzki, MD, PD University hospitals of Geneva
Study Chair: Martin R Tramèr, MD, PhD University hospitals of Geneva
Principal Investigator: Christian Kern, MD, Prof University Hospitals of Lausanne, Switzerland
  More Information

No publications provided

Responsible Party: Christoph Czarnetzki, Responsable Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01571908     History of Changes
Other Study ID Numbers: CER 11-235
Study First Received: April 3, 2012
Last Updated: September 21, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
rocuronium
succinylcholine
magnesiumsulphate
intubation conditions

Additional relevant MeSH terms:
Succinylcholine
Rocuronium
Magnesium Sulfate
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Neuromuscular Nondepolarizing Agents

ClinicalTrials.gov processed this record on May 22, 2013