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Measurement of Accuracy and Bias in Two Neuromuscular Monitoring Methods in Patients Aged 18 Years and over comparing acceleromyography (AMG) and electromyography (EMG) using the Stimpod NMS450X

The accuracy, bias, and limits of agreement between acceleromyography (AMG) and electromyography (EMG) measurements using the Stimpod NMS450X during rocuronium-induced neuromuscular blockade in patient aged 18 years and over.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000936426
Enrollment
29
Registered
2025-08-28
Start date
2024-07-16
Completion date
2026-03-30
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We planned to compare AMG and EMG data provided simultaneously by the new Stimpod on one hand simply installed in supine position on a board. The primary outcome is to compare their precision during initial stable baseline, and the bias and limits of agreement during several stages of neuromuscular blockade recovery quantified successively by Post Tetanic Count, Train Of Four (TOF) count and TOF ratio. In the case of a significant bias between AMG and EMG, secondary outcomes are to evaluate the interest of different levels of AMG recovery (T4/T1 0.95 and 1.0), software solution for normalization, and alternate ways of calculating TOF ratio (T4/T2 or T5/T2) to reduce the bias.

Interventions

The inclusion of patients in the study implies the systematic use of the Stimpod. Data collection is carried out during surgery until complete muscle recovery for at least 10 minutes. Data is collected using proprietary electrodes applied to the wrist and thumb placed on the opposite side of the tensiometer to minimize artefacts.The placement of the electrodes is performed by an anesthesiologist once the patient is positioned on the operating table. This step therefore takes place while the pat

The inclusion of patients in the study implies the systematic use of the Stimpod. Data collection is carried out during surgery until complete muscle recovery for at least 10 minutes. Data is collected using proprietary electrodes applied to the wrist and thumb placed on the opposite side of the tensiometer to minimize artefacts.The placement of the electrodes is performed by an anesthesiologist once the patient is positioned on the operating table. This step therefore takes place while the patient is awake. The collection of AMG and EMG data then begins as soon as the patient loses consciousness during the induction of anesthesia. This data collection is continuous and varies according to the stages of the patient's neuromuscular blockade. During the deep blockade phase (that is, when there is no muscle response to the train-of-four stimulation), Stimpods collect data every 5 minutes (AMG + EMG). During the other phases, data is collected every 15 seconds until the end of the surgical procedure. Thus, this is not a one-off collection at specific stages, but rather a continuous collection throughout the entire duration of anesthesia.

Sponsors

Quentin Delhez CHU UCL Namur Belgium
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients with American Society of Anesthesiologists (ASA) grades I–II (aged 18 and over) scheduled to undergo rhinoplasty or rhinoseptoplasty under general anesthesia were included in this study.

Exclusion criteria

The exclusion criteria were as follows: pregnant or breastfeeding women, patients with renal or hepatic insufficiency, patients with neurological disorders, any patient with a suspected allergy to the drugs used in the protocol, or those receiving medications that could interfere with neuromuscular transmission

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026