Intubation ConditionsPhase 2MagInRocNCT01571908
Rapid Sequence Intubation With Magnesium-rocuronium Compared With Succinylcholine - A Randomised Clinical Study
A Phase 2 study testing Magnesium perfusion, Rocuronium and Succinylcholine in people with Intubation Conditions, run by University Hospital, Geneva at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intubation Conditions
- What is being tested?
- Magnesium perfusion, Rocuronium and Succinylcholine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Sep 2012to Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital of Geneva, Anesthesia Department
Geneva, Canton of Geneva, 1211
Division of Anaesthesiology, University Hospital of Lausanne (CHUV)
Lausanne, Canton of Vaud, 1011
About this study
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)
Read the 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.
- Conditions
- Intubation Conditions
- Being tested
- Magnesium perfusion, Rocuronium, Placebo perfusion, Succinylcholine
- Keywords
- rocuronium, succinylcholine, magnesiumsulphate, intubation conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium perfusionDrug
Also called Magnesium
The patient receives during 15 minutes a perfusion of 60mg/kg of Magnesium sulphate before induction of anaesthesia.
RocuroniumDrug
Also called Zemuron
Immediately after anaesthesia induction and loss of consciousness 0,6 mg/kg of rocuronium will be injected
Placebo perfusionDrug
Also called Saline
The patient receives during 15 minutes a perfusion of 1 ml/kg of saline before induction of anaesthesia
SuccinylcholineDrug
Also called Anectine
Immediately after anaesthesia induction at loss of consciousness 1 mg/kg of succinylcholine will be injected
| Study group | Role | What they receive |
|---|---|---|
| Magnesium perfusion - Rocuronium | Experimental | 60 mg/kg of magnesium perfusion over 15 minutes before Anaesthesia. After Anaesthesia induction 0.6 mg/kg of Rocuronium intravenously Receives: Drug: Magnesium perfusion; Drug: Rocuronium |
| Placebo perfusion - Succinylcholine | Active comparator | 1ml/kg of saline (placebo) over 15 minutes before Anaesthesia. After Anaesthesia induction 1 mg/kg of Succinylcholine intravenously Receives: Drug: Placebo perfusion; Drug: Succinylcholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation score
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").
Measured: Patient will be followed over 24 hours
Secondary outcomes (2)
Signs of histamine release
Immediately after intubation, patients will be evaluated for signs of histamine release (bronchospasm, erythema, oedema).
Measured: From start of anesthesia induction upto 30 minutes after intubation
awareness and muscle pain
The day after surgery, patients will be visited and will be screened for awareness and muscle pain.
Measured: 24 hour follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Principal investigator, Christoph Czarnetzki, University Hospital, Geneva
- Investigators
- Christoph Czarnetzki, MD, PD, Principal investigator, University Hospitals of GenevaMartin R Tramèr, MD, PhD, Study chair, University Hospitals of GenevaChristian Kern, MD, Prof, Principal investigator, University Hospitals of Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571908
- Sponsor's protocol ID
- CER 11-235
- Acronym
- MagInRoc
- Status last verified
- May 2015
- First submitted
- 3 Apr 2012
- Last updated
- 20 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Czarnetzki C, Albrecht E, Masouye P, Baeriswyl M, Poncet A, Robin M, Kern C, Tramer MR. Rapid Sequence Induction With a Standard Intubation Dose of Rocuronium After Magnesium Pretreatment Compared With Succinylcholine: A Randomized Clinical Trial. Anesth Analg. 2021 Dec 1;133(6):1540-1549. doi: 10.1213/ANE.0000000000005324.
PubMed 33337797
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Sequence Intubation With Magnesium-rocuronium Compared With Succinylcholine - A Randomised Clinical Study
- ClinicalTrials.gov ID
- NCT01571908
- Acronym / sponsor ID
- MagInRoc / CER 11-235
- Conditions
- Intubation Conditions
- Keywords
- rocuronium, succinylcholine, magnesiumsulphate, intubation conditions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Study start
- Sep 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium perfusion - Rocuronium | Experimental | Drug: Magnesium perfusion, Drug: Rocuronium60 mg/kg of magnesium perfusion over 15 minutes before Anaesthesia. After Anaesthesia induction 0.6 mg/kg of Rocuronium intravenously |
| Placebo perfusion - Succinylcholine | Active comparator | Drug: Placebo perfusion, Drug: Succinylcholine1ml/kg of saline (placebo) over 15 minutes before Anaesthesia. After Anaesthesia induction 1 mg/kg of Succinylcholine intravenously |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium perfusionAlso: MagnesiumThe patient receives during 15 minutes a perfusion of 60mg/kg of Magnesium sulphate before induction of anaesthesia. | Drug | Magnesium perfusion - Rocuronium |
| RocuroniumAlso: ZemuronImmediately after anaesthesia induction and loss of consciousness 0,6 mg/kg of rocuronium will be injected | Drug | Magnesium perfusion - Rocuronium |
| Placebo perfusionAlso: SalineThe patient receives during 15 minutes a perfusion of 1 ml/kg of saline before induction of anaesthesia | Drug | Placebo perfusion - Succinylcholine |
| SuccinylcholineAlso: AnectineImmediately after anaesthesia induction at loss of consciousness 1 mg/kg of succinylcholine will be injected | Drug | Placebo perfusion - Succinylcholine |
Primary outcome
Intubation score
Time frame: 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").
2 secondary outcomes
Signs of histamine release
Time frame: From start of anesthesia induction upto 30 minutes after intubation
awareness and muscle pain
Time frame: 24 hour follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2015.
- Derived from this study: PubMed 33337797Czarnetzki C, Albrecht E, Masouye P, Baeriswyl M, Poncet A, Robin M, Kern C, Tramer MR. Rapid Sequence Induction With a Standard Intubation Dose of Rocuronium After Magnesium Pretreatment Compared With Succinylcholine: A Randomized Clinical Trial. Anesth Analg. 2021 Dec 1;133(6):1540-1549. doi: 10.1213/ANE.0000000000005324.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Czarnetzki, MD, PD principal investigator
University Hospitals of Geneva
Martin R Tramèr, MD, PhD study chair
University Hospitals of Geneva
Christian Kern, MD, Prof principal investigator
University Hospitals of Lausanne, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnesium perfusion, Rocuronium and Succinylcholine in people with Intubation Conditions, run by University Hospital, Geneva at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation score (time frame: Patient will be followed over 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01571908, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2015.