How long rocuronium lasts when given subcutaneously to adult surgical patients

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001215617
• Date of registration: 19/11/2014
• Prospective Registration: Yes
• Primary sponsor: Fremantle Hospital
• Public title: How long rocuronium lasts when given subcutaneously to adult surgical patients
• Scientific title: A double-blinded randomised clinical trial comparing the time of onset, duration and clinical effects of subcutaneous vs intravenous rocuronium in adult surgical patients
• Date of first enrolment: 01/02/2015
• Target sample size: 20
• Recruitment status: Withdrawn
• URL: https://anzctr.org.au/ACTRN12614001215617.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Pharmacokinetics / pharmacodynamics;
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: Dr Sam Wong

• Name: Dr Sam Wong

Key inclusion & exclusion criteria

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)

Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Inadvertent subcutaneous injection of rocuronium;
Inadvertent subcutaneous injection of rocuronium

Anaesthesiology - Anaesthetics

Intervention(s)

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

Primary Outcome(s)

Duration of muscle relaxation until train-of-four ratio recovers to 90% as measured by NMT (neuro-muscular transmission) kinemyography monitor[Every 5 minutes during surgery until muscle relaxation resolves]

Secondary Outcome(s)

Time from administration of rocuronium until the greatest degree of muscle relaxation occurs as measured by NMT (neuro-muscular transmission) kinemyography monitor[Every 20 seconds following administration of rocuronium until greatest degree of muscle relaxation occurs]

Time from administration of rocuronium until a train-of-four count of 1/4 returns as measured by NMT (neuro-muscular transmission) kinemyography monitor[Every 5 minutes during surgery until muscle relaxation recovers to a train-of-four count of 1/4]

Time from administration of rocuronium until the first twitch height recovers from 25% of baseline to 75% of baseline as measured by NMT (neuro-muscular transmission) kinemyography monitor (recovery index)[Every 5 minutes during surgery until muscle relaxation recovers from a first twitch of 25% to 75% of baseline]

Time from administration of rocuronium until a train-of-four count of 2/4 returns as measured by NMT (neuro-muscular transmission) kinemyography monitor[Every 5 minutes during surgery until muscle relaxation recovers to a train-of-four count of 2/4]

Greatest degree of muscle relaxation produced by rocuronium as measured by NMT (neuro-muscular transmission) kinemyography monitor[Every 20 seconds following administration of rocuronium until greatest degree of muscle relaxation occurs]

Time from administration of rocuronium until train-of-four count falls to 0/4 as measured by NMT (neuro-muscular transmission) kinemyography monitor[Every 20 seconds following administration of rocuronium until specified degree of muscle relaxation occurs]

Secondary ID(s)

None

Source(s) of Monetary Support

Department of Anaesthesia, Fremantle Hospital

Ethics review

Status: Not approved
Approval date:
Contact:

South Metropolitan Health Service Human Research Ethics Committee