N/A
N=100
Train-of-four Monitoring Using the Tetragraph
Surgery
Bottom Line
View on ClinicalTrials.gov: NCT04475250 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Baseline TOFr (%) — 100.1 percent
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tetragraph (TM) NMT Monitor (Device)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Joseph D. Tobias
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline TOFr (%) |
100.1 | — |
| PRIMARY Recovered TOFr (%) |
90.1 | — |
| SECONDARY Baseline Amplitude (mV) |
7.5 | — |
| SECONDARY Recovered Amplitude (mV) |
6.5 | — |
| SECONDARY Rate of Muscle Recovery (Minutes) |
2.6 | — |
Summary
This is a prospective study that will evaluate the feasibility of using the Tetragraph Neuromuscular Transmission Monitor in comparison to standard (visual) train-of-four assessment with a peripheral nerve stimulator in pediatric patients undergoing surgery.
Eligibility Criteria
Inclusion Criteria
- Pediatric patients requiring anesthetic care and use of neuromuscular blockade
- Weight range of 20 - 60 kg
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 not required
- Edematous patients
Data sourced from ClinicalTrials.gov (NCT04475250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.