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WithdrawnPhase 4ACTRN12614001215617

How long rocuronium lasts when given subcutaneously to adult surgical patients

A double-blinded randomised clinical trial comparing the time of onset, duration and clinical effects of subcutaneous vs intravenous rocuronium in adult surgical patients

Sponsor

Fremantle Hospital

Enrollment

20 participants

Start Date

Feb 1, 2015

Study Type

Interventional

Conditions

Inadvertent subcutaneous injection of rocuronium

Summary

This study will examine the effects of rocuronium, a non-depolarising muscle relaxant when given subcutaneously. In this study, we will compare the effects of subcutaneous rocuronium against intravenous rocuronium. We will measure how long until it works, how much effect it has and how long it lasts.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 64 Yearss

Inclusion Criteria4

  • Elective or semi-elective surgery (surgery not required within 24 hours of being booked)
  • Age 18-64
  • Expected duration of anaesthesia >6 hours
  • Planned admission to the intensive care unit after surgery

Exclusion Criteria11

  • Emergency surgery (surgery within 24 hours of procedure being booked)
  • Patients unable to give informed consent
  • Severe renal impairment (eGFR <30ml/min)
  • Significant hepatic impairment (known history of cirrhosis or liver dysfunction)
  • History of neuromuscular disease (e.g. poliomyelitis, myasthenia gravis, eaton-lambert syndrome)
  • Patients taking long term medications: lithium, phenytoin, carbamazepine
  • Administration of other muscle relaxant in previous 24 hours (suxamethonium or other non-depolarising muscle relaxant)
  • Pregnant or breastfeeding women
  • Patients requiring muscle relaxation to facilitate surgery
  • Patients having surgery where muscle relaxation is contraindicated
  • Significant possibility of anaesthetic ending prior to 6 hours (for instance – intra-abdominal surgery that may be abandoned due to disease progression that can only be decided after starting operation)

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Interventions

0.6mg/kg subcutaneous rocuronium, single bolus dose administered following induction of anaesthesia prior to commencement of surgery

0.6mg/kg subcutaneous rocuronium, single bolus dose administered following induction of anaesthesia prior to commencement of surgery

Locations(2)

Fremantle Hospital and Health Service - Fremantle

WA, Australia

Fiona Stanley Hospital - Murdoch

WA, Australia

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ACTRN12614001215617