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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001215617

Enrollment

Registered

2014-11-19

Start date

2015-02-01

Completion date

2016-02-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

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 criteria

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)

Outcome results