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

NCT01571908 | Completed Phase 2 DMC

• 1 other identifier: CER 11-235
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Intubation Conditions

Keywords

rocuronium; succinylcholine; magnesiumsulphate; intubation conditions

Outcome Measures

Primary Outcomes (1)

• 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").

  Patient will be followed over 24 hours

Secondary Outcomes (2)

• Signs of histamine release

  From start of anesthesia induction upto 30 minutes after intubation

• awareness and muscle pain

  24 hour follow up

Study Arms (2)

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

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

Drug: Placebo perfusion; Drug: Succinylcholine

Interventions

Magnesium perfusion DRUG

The patient receives during 15 minutes a perfusion of 60mg/kg of Magnesium sulphate before induction of anaesthesia.

Also known as: Magnesium

Magnesium perfusion - Rocuronium

Rocuronium DRUG

Immediately after anaesthesia induction and loss of consciousness 0,6 mg/kg of rocuronium will be injected

Also known as: Zemuron

Magnesium perfusion - Rocuronium

Placebo perfusion DRUG

The patient receives during 15 minutes a perfusion of 1 ml/kg of saline before induction of anaesthesia

Also known as: Saline

Placebo perfusion - Succinylcholine

Succinylcholine DRUG

Immediately after anaesthesia induction at loss of consciousness 1 mg/kg of succinylcholine will be injected

Also known as: Anectine

Placebo perfusion - Succinylcholine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead
• University of Lausanne Hospitals: collaborator

Study Sites (2)

University Hospital of Geneva, Anesthesia Department

Geneva, Canton of Geneva, 1211, Switzerland

Location

Division of Anaesthesiology, University Hospital of Lausanne (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 33337797 DERIVED

MeSH Terms

Interventions

Magnesium; Rocuronium; Sodium Chloride; Succinylcholine

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds

Study Officials

• Christoph Czarnetzki, MD, PD

  University hospitals of Geneva

  PRINCIPAL INVESTIGATOR

• Martin R Tramèr, MD, PhD

  University hospitals of Geneva

  STUDY CHAIR

• Christian Kern, MD, Prof

  University Hospitals of Lausanne, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsable Investigator

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 5, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 20, 2015

Record last verified: 2015-05

Locations

CH (2)