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NICU guideline identifier

Rocuronium (Rocuronium Bromide)

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Dose and administration

To facilitate tracheal intubation:

IV bolus: 0.6mg/kg (0.4mg-1mg) over 5-10 seconds.1-3,5,6,9

Sustained skeletal muscle relaxation:
• For Atrial Balloon Septostomy use 1mg/kg
• IV bolus: 600 micrograms/kg (400-1000micrograms/kg) over 5-10 seconds.1-3,5,6,9
• Can be repeated every 30-60 minutes as required.1-3,5,6

Rocuronium has a short onset of action (60-90 seconds) and intermediate duration of action (20-40 minutes). Duration may be prolonged with higher doses and in pre-term infants.4,5

Indications

  1. Adjunct to general anaesthesia to facilitate tracheal intubation.1-5
  2. To provide skeletal muscle relaxation during surgeries or mechanical ventilation.1-5

Proposed desirable effects are improved oxygenation from improved lung compliance in ventilated newborn infants, reduced barotrauma and reduced cerebral blood flow fluctuations

Contraindications and precautions

  1. Hypersensitivity to rocuronium or any component of formulation1,3,5
  2. Cross-reactivity may occur in patients with previous anaphylactic reactions to other neuromuscular-blocking agents (NMBA).1,3,5
  3. Associated with increased pulmonary vascular resistance, particularly in patients with valvular heart disease or pulmonary hypertension.5
  4. Duration of neuromuscular blockade can be decreased by:
    1. Alkalosis
    2. Hyperkalaemia, hypercalcaemia1,5,4
    3. Steroids, anti-epileptics (see "Drug interactions" under "Special Considerations")4
  5. Duration of neuromuscular blockade can be increased by:
    1. Hepatic and/or renal impairment1,3,5
    2. Acidosis, neuromuscular disease (e.g. myasthenia gravis, Eaton Lambert syndrome, amyotrophic lateral sclerosis)
    3. Hypokalaemia, hypermagnesemia*, severe hypocalcaemia, cachexia and hypothermia1,5
    4. General anaesthetics, aminoglycosides, muscle relaxants (see "Drug interactions" under "Special Considerations")4

*Caution is recommended in neonates of mothers that received magnesium sulphate infusion (e.g. for pre-eclampsia or fetal neuro-protection).

Clinical pharmacology

Rocuronium bromide is a fast onset, intermediate acting non-depolarizing NMBA.1-3,5
It produces skeletal muscle relaxation by competitively binding to the nicotinic acetylcholine receptors of motor end-plates responsible for voluntary muscles.1,5

Possible adverse effects

  1. Tachycardia and blood pressure changes (both hypotension and hypertension)1,5
  2. Apnoea from inadequate mechanical ventilation and/or deterioration in pulmonary mechanics5
  3. QT prolongation (risk increased with concurrent general anaesthetics)6
  4. Prolonged paralysis (risk increased with chronic administration)1,5
  5. Malignant hyperthermia1,5
  6.  Anaphylaxis (rare)5

Special considerations

  1. Administer only to babies about to be intubated or already intubated.1
  2. Must be accompanied by adequate anesthesia or sedation (NMBAs including rocuronium do not provide sedative or analgesic effects).1,5
  3. Infants with neuromuscular disease (e.g. myasthenia gravis or Eaton-Lambert syndrome) may get profound effects from small doses of NMBAs.6
  4. Eye care - eyelids should remain closed with lubricants (e.g. drops, gel, or ointment) to prevent corneal drying and/or ulceration during neuromuscular blockade.1,5
  5. Drug interactions:
    General anaesthesia (e.g. isoflurane, thiopental, ketamine, etomidate, propofol)
    May prolong neuromuscular blockade and cause QT prolongation4-6
    Aminoglycosides, metronidazole, vancomycin
    May enhance and/or prolong neuromuscular blockade and lead to respiratory depression and paralysis.5,4
    Chronic steroid use
    Have been associated with prolonged recovery from neuromuscular blockade and acute quadriplegic myopathy syndrome (AQMS).4,5,8
    Adult guidelines recommend withholding corticosteroid therapy until necessary to restart (based on clinical condition), or discontinuing NMBAs in patients on corticosteroids as soon as possible.8
    Chronic anti-epileptic therapy (e.g. phenytoin, carbamazepine, phenobarbitone)
    Can shorten durations of neuromuscular block - higher or more frequent doses of rocuronium may be required.6,4
  6. Antidote:
    In the event of overdose and prolonged neuromuscular block, management involves ventilator support, sedation and reversal with:
    1. Neostigmine (60 micrograms/kg)1,3,5 AND
    2. Atropine (20 micrograms/kg)1,3,5
    Sugammadex is also effective for rocuronium reversal in adults, but has not been systemically studied in neonates or infants.3,5

Management of Rocuronium administration

Description

Clear, colourless to faint yellow solution. Available in 5mL vials containing 10mg/mL.3

Prescription

  1. Rocuronium is charted under PRN on the prescription chart in mg/kg
  2. May be needed and given as frequently as every 30-60 minutes.1-3,5

Administration

IV Injection

  1. To prepare a 1mg/mL solution: draw up 1mL of the 10mg/1mL solution and dilute to a final volume of 10mL with sodium chloride 0.9%.5 No further dilution is required.
  2. Filter prior to administration through a Pall 0.2 micron filter.
  3. Diluted solution is stable for 24 hours.5
  4. Compatible solutions: Sodium chloride 0.9%, glucose 5%/sodium chloride 0.9%, glucose 5%3-5,7
    Compatible via Y-site: Heparin, midazolam3-5,7
    Incompatible via Y-Site: Lipid, amoxicillin, amphotericin, cephazolin, dexamethasone, diazepam, erythromycin, frusemide, hydrocortisone, insulin, phenobarbitone, methylprednisolone, prednisolone, vancomycin3-5,7
  5. Do not mix with alkaline solutions (e.g. barbiturate solutions) in the same syringe3-5,7
  6. Adequately flush line before and after administration to avoid unintended paralysis during later use of the line.5

Observation and documentation

  1. Continuous cardiorespiratory, pulse oximetry and arterial blood pressure monitoring.6
  2.  Close monitoring of neuromuscular function recommended as residual paralysis after extubation and/or prolonged paralysis may occur while weaning from ventilator.6
  3. Careful airway care to remove secretions.
  4. Careful positioning and changes of position.
  5. Monitor fluid balance.
  6. Express bladder PRN.
  7. Keep resuscitation equipment near bedside.
  8. Consider if ECG monitoring medically warranted - QT prolongation has been reported with overall ECG data in paediatric patients.6
  9. For neonates with neuromuscular disease, consider if continuous nerve transmission monitoring with a peripheral nerve stimulator is indicated.6

Storage

  1. Store vials unopened in a refrigerator at 2-8°C.3
  2. Upon removal from refrigerator to room temperature (8-25°C), use within 12 weeks.
  3. Any vials removed from refrigerator should not be returned to the refrigerator.3
  4. Doses should be completed within 24 hours of opening vial. Any unused solutions should be discarded.1,3,4

Selected references

  1. UpToDate: Rocuronium Drug Information. Accessed on 2nd December 2018.
  2. Barry, P. and Leslie, A. (2003) Paediatric and Neonatal Critical Care Transport, London: BMJ Books
  3. Pfizer New Zealand Limited. [DBLTM Rocuronium Bromide Injection 50mg/5mL Vial] Data sheet [prepared 21/3/17] www.medsafe.govt.nz/profs/Datasheet/d/dblrocuroniuminj.pdf (accessed 2/12/18)
  4. Evelina London Paediatric Formulary (formerly Guy's & St Thomas' Paediatric Formulary). Accessed 2/12/18.
  5. Neofax. Accessed via Micromedex on 4/12/18.
  6. Micromedex solutions. Accessed on 5/12/18
  7. Trissel's™ Clinical Pharmaceutics Database (Parenteral Compatibility) - accessed via Micromedex Solutions on 4/12/18
  8. Murray MJ, Cowen J, DeBlock H, et al, Clinical Practice Guidelines for Sustained Neuromuscular Blockade in the Adult Critically Ill Patient. Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists, American College of Chest Physicians. Crit Care Med 2002;30(1):142-56.
  9. Neonatal Formulary 5, Drug use in Pregnancy and First Year of Life, 2007, Blackwell Publishing
  10. Shann F. "Drug Doses" pocket dose guide 1998 (10th Ed.):45

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Document Control

  • Date last published: 17 December 2018
  • Document type: Clinical Guideline
  • Services responsible: Neonatology, ADHB Pharmacy
  • Author(s): Natasha Pool, Regina Cheng, Sarah Bellhouse
  • Editor: Sarah Bellhouse
  • Review frequency: 2 years