N/A
Completed N=40
Tetragraph® Monitor: Tolerance of Preoperative Placement
Surgery
Source: ClinicalTrials.gov NCT05964166 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Tolerance to Preop Placement as Assessed by Likert Scale — 0; 10; 0; 10 units on a scale (0-10)
Summary
This is a prospective, non-blinded, single arm study. The primary objective of this study is to evaluate the tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor in pediatric-sized patients ≤ 12 years of age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerance to Preop Placement as Assessed by Likert Scale |
0; 10; 0; 10 | — |
| SECONDARY Application Ease |
4; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Patients requiring anesthetic care and use of neuromuscular blockade
- Age ≤ 12 years
- ASA 1-4
Exclusion Criteria
- History of a peripheral neurologic or neuropathic disorder
- Upper extremity cannot be used for TOF monitoring
- Undergoing a surgical procedure in which neuromuscular blockade is not required
- Patient is edematous
- Patients with significant behavioral or neurocognitive issues which affect behavior and impact the ability to place the sensor
Data sourced from ClinicalTrials.gov (NCT05964166). 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. Informational only — not medical advice.