Clinical trial NCT05294523: Rocuronium and Supramaximal Stimulation
Official title: Priming Dose of Rocuronium and Milliamperage Value for Supramaximal Stimulation of NeuroMuscular Transmission Monitor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuromuscular Blockade
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To shorten induction time, some anesthesiologist gives a priming dose of muscle relaxant before starting Neuromuscular Transmission monitor (NMT). To properly evaluate neuromuscular function during the surgury, baseline supramaximal stimulation of the monitored nerve is mandatory. Not knowing if the priming dose of muscle relaxant affects the supramaximal stimulation current setting, The investigators designed this study to find out.

Detailed description: The NMT monitor module automatically determines the current needed for the supramaximal stimulus, and maintains this current throughout the procedure.

The supramaximal current is the current above which there is no increase in the evoked muscle response. At this stimulus current, all motor units are firing in response to nerve stimulation. According to previous studies, the current was significantly increased in the presence of edema and peripheral neuropathy. In this study, the route of administration, dosage, dosage regimen, and treatment period are basically the same as the investigators anesthesia department's routine procedure for general anesthesia. The difference will be the time the investigators set between the priming dose to final dose of rocuronium is 2 minutes. The investigators use 2 minutes as the peak effect of rocuronium is 105±36S.

To properly evaluate neuromuscular blockade during the surgery, baseline supramaximal stimulation of the monitored nerve is mandatory. Not knowing if the priming dose of muscle relaxant affects the supramaximal stimulation current setting, the investigators designed this study.

Eligibility criteria: Inclusion Criteria:

* Patients receiving general anesthesia and use rocuronium for induction

Exclusion Criteria:

* Muscular disease
* Peripheral neuropathy
* Difficult airway or difficult mask ventilation
* Allergy to study related medication
* Pregnant woman
* \< 20-year-old or \> 65-year-old
* BMI \<18.5 or BMI\>24.9

Primary outcomes:
measure: Supramaximal stimulation value
timeFrame: since general anesthesia induction to endotracheal tube intubation, about 10 minutes
Secondary outcomes:
measure: supramaximal stimulation value change by time
timeFrame: since general anesthesia induction to endotracheal tube intubation, about 10 minutes
measure: dose of rocuronium
timeFrame: since general anesthesia induction to endotracheal tube intubation, about 10 minutes
measure: Time to intubation
timeFrame: since general anesthesia induction to endotracheal tube intubation, about 10 minutes
measure: Intubation condition
timeFrame: since general anesthesia induction to endotracheal tube intubation, about 10 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Taipei Medical University Hospital
name: Wei Chieh Lai, MD, MPH
role: STUDY_CHAIR
References:
citation: Kopman AF, Lawson D. Milliamperage requirements for supramaximal stimulation of the ulnar nerve with surface electrodes. Anesthesiology. 1984 Jul;61(1):83-5. No abstract available.
citation: Naguib M, Brull SJ, Kopman AF, Hunter JM, Fulesdi B, Arkes HR, Elstein A, Todd MM, Johnson KB. Consensus Statement on Perioperative Use of Neuromuscular Monitoring. Anesth Analg. 2018 Jul;127(1):71-80. doi: 10.1213/ANE.0000000000002670.
citation: Armendariz-Buil I, Lobato-Solores F, Aguilera-Celorrio L, Morros-Diaz E, Fraile-Jimenez E, Vera-Bella J. Residual neuromuscular block in type II diabetes mellitus after rocuronium: a prospective observational study. Eur J Anaesthesiol. 2014 Aug;31(8):411-6. doi: 10.1097/01.EJA.0000435022.91954.8d.
citation: Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.