An Evaluation of the Neuromuscular Junction in Neonates Using the TetraGraph
ConditionSurgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age28-25
SponsorJoseph D. Tobias
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
TetraGraph
DeviceTetraGraph 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: InfantsExperimental treatment 1 intervention
Group B: AdolescentsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Amplitude
Average amplitude of the evoked response of the muscles.
Time frame
First 30 minutes of surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Joseph D. Tobias
Lead sponsor
Nationwide Children's Hospital
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: