An Evaluation of the Neuromuscular Junction in Neonates Using the TetraGraph

Joseph D. Tobias

Status: Not yet enrolling

Conditions: Surgery

Treatments: Device: TetraGraph

Study type: Interventional

Funder types: Other

Identifiers

NCT07133412

STUDY00005296

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 28 days to 25 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Infants

Experimental group

Description:

Infants 28 days to 3 months old undergoing surgery.

Treatment:

Device: TetraGraph

Adolescents

Active Comparator group

Description:

Adolescents/young adults 12 years of age or above undergoing surgery.

Treatment:

Device: TetraGraph