Rocuronium and Supramaximal Stimulation

Priming Dose of Rocuronium and Milliamperage Value for Supramaximal Stimulation of NeuroMuscular Transmission Monitor

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.

Study Overview

• Status: Recruiting
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Procedure: Rocuronium priming dose

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Chieh LAI, MD, MPH; Phone Number: +886919141289; Email: ndicy@yahoo.com.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 220
    • Recruiting
    • Taipei Medical University Hospital
    • Contact: Wei Chieh LAI, MD, MPH; Phone Number: +886919141289; Email: ndicy@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rocuronium priming dose 0.06mg/kg; Add the priming dose of rocuronium 0.06mg/kg after the first supramaximal stimulation data measured	Procedure: Rocuronium priming dose; Add the priming dose of rocuronium after the first supramaximal stimulation data measured
Active Comparator: Rocuronium priming dose 0.12mg/kg; Add the priming dose of rocuronium 0.12mg/kg after the first supramaximal stimulation data measured	Procedure: Rocuronium priming dose; Add the priming dose of rocuronium after the first supramaximal stimulation data measured
Active Comparator: Rocuronium priming dose 0.18mg/kg; Add the priming dose of rocuronium 0.18mg/kg after the first supramaximal stimulation data measured	Procedure: Rocuronium priming dose; Add the priming dose of rocuronium after the first supramaximal stimulation data measured

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supramaximal stimulation value	whether the supramaximal stimulation changs after 2 minutes of priming dose of muscle relaxant use	since general anesthesia induction to endotracheal tube intubation, about 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
supramaximal stimulation value change by time	whether the supramaximal stimulation changs have a trend	since general anesthesia induction to endotracheal tube intubation, about 10 minutes
dose of rocuronium	whether the change of supramaximal stimulation change is muscle relaxant dose responsive	since general anesthesia induction to endotracheal tube intubation, about 10 minutes
Time to intubation	how long does it take from the full dose of muslce relaxant given to TOF count <2	since general anesthesia induction to endotracheal tube intubation, about 10 minutes
Intubation condition	the intubation condition with priming method used. Evaluate with scoring scale. scale range from 0-3. 0 presented as poor Jaw relaxation, closed vocal cord, and severe cough or bucking when intubation; to 3 represent a condition with good jaw relaxation, open vocal cord, and no repsponse to stimulation.	since general anesthesia induction to endotracheal tube intubation, about 10 minutes

Collaborators and Investigators

• Sponsor: Taipei Medical University Hospital
• Investigators: Study Chair: Wei Chieh Lai, MD, MPH, Taipei Medical University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Diabetes Mellitus and Neuromuscular Blockade: Review

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 27, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: N202109050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: de-identified raw data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No