An Evaluation of the Neuromuscular Junction in Neonates Using the TetraGraph
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TetraGraph.
- Who it may be relevant to
- Registry conditions: Surgery. Basic parameters: 28 Days — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Evaluation of the Neuromuscular Junction in Infants Using Train-of-four Monitoring With the TetraGraph™ Neuromuscular Transmission Monitor
Overview
The goal of this study is to use electromyography-based train-of-four monitoring (TetraGraph™ Neuromuscular Transmission Monitor) as a means of evaluating differences in neuromuscular transmission between infants ≤ 3 months of age and adolescent and older patients (≥ 12 years of age).
Interventions
- Device TetraGraph
TetraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.
Primary outcome measures
- Amplitude [Time frame: First 30 minutes of surgery]
Eligibility criteria
Inclusion criteria
- ASA 1-3 patients
- Aged 28 days - 3 months or ≥ 12 years
- Undergoing a surgical procedure with a volatile-agent based anesthetic that does not require administration of a neuromuscular blocking agent
Exclusion criteria
- Patients with history of a peripheral neurologic or neuropathic disorder
- Patients in whom the upper extremity cannot be used for TOF monitoring
- Patients undergoing a surgical procedure in which neuromuscular blockade is required
- Edematous patients
- Patients receiving total intravenous anesthesia (TIVA)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Nationwide Children's Hospital — Columbus
Identifiers
NCT: NCT07133412 · STUDY00005296