Rapid Sequence Intubation With Magnesium-rocuronium Compared With Succinylcholine - A Randomised Clinical Study (MagInRoc)
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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 |
- 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").
- 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 |
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| Contact: Christoph A Czarnetzki, MD, MBA | 0041223723311 | christoph.czarnetzki@hcuge.ch |
| Contact: Martin R Tramèr, MD, PhD | 0041223723311 | martin.tramer@hcuge.ch |
| 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 | |
| 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