Rocuronium and Supramaximal Stimulation

Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05294523
• Other study ID #: N202109050
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2022
• Source: Taipei Medical University Hospital
• Contact: Wei Chieh Lai, MD, MPH
• Phone: +886919141289
• Email: ndicy[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Procedure:
• Rocuronium priming dose
Add the priming dose of rocuronium after the first supramaximal stimulation data measured

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Diabetes Mellitus and Neuromuscular Blockade: Review