N/A
N=50
TOF Monitoring Using the TetraGraph in Patients Less Than 1 Year of Age
Surgery
Bottom Line
View on ClinicalTrials.gov: NCT06458023 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: TOFr (%) — 99; 95 percent
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TetraGraph (TM) NMT Monitor (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Joseph D. Tobias
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY TOFr (%) |
99; 95 | — |
| PRIMARY Amplitude |
6.8; 4.7 | — |
| SECONDARY Rate of Muscle Recovery |
2.7 | — |
Summary
The primary objective of this study is to evaluate the efficacy of train-of-four (TOF) monitoring using the TetraGraph Neuromuscular Transmission Monitor in pediatric patients less than 1 year of age.
Eligibility Criteria
Inclusion Criteria
- ASA 1-4
- ≤ 1 year of age
- undergoing a surgical procedure with general anesthesia and requiring the administration of an NMBA
Exclusion Criteria
- Patients less than 28 days old
- 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 (NCT06458023). 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.