Rocuronium and Supramaximal Stimulation

Not Applicable

Recruiting

• Conditions: Neuromuscular Blockade
• Interventions: Procedure: Rocuronium priming dose

• Registration Number: NCT05294523
• Lead Sponsor: Taipei Medical University Hospital

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.

Study Timeline

• Study Start: 2021-12-20
• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-24
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-27
• Last Update Posted: 2022-11-29
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rocuronium priming dose 0.06mg/kg	Rocuronium priming dose	Add the priming dose of rocuronium 0.06mg/kg after the first supramaximal stimulation data measured
Rocuronium priming dose 0.12mg/kg	Rocuronium priming dose	Add the priming dose of rocuronium 0.12mg/kg after the first supramaximal stimulation data measured
Rocuronium priming dose 0.18mg/kg	Rocuronium priming dose	Add the priming dose of rocuronium 0.18mg/kg after the first supramaximal stimulation data measured

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
dose of rocuronium	since general anesthesia induction to endotracheal tube intubation, about 10 minutes	whether the change of supramaximal stimulation change is muscle relaxant dose responsive
supramaximal stimulation value change by time	since general anesthesia induction to endotracheal tube intubation, about 10 minutes	whether the supramaximal stimulation changs have a trend
Time to intubation	since general anesthesia induction to endotracheal tube intubation, about 10 minutes	how long does it take from the full dose of muslce relaxant given to TOF count \<2
Intubation condition	since general anesthesia induction to endotracheal tube intubation, about 10 minutes	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.

Trial Locations

Locations (1)

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan