An Evaluation of the Neuromuscular Junction in Neonates Using the TetraGraph

NCT ID: NCT07133412

Last Updated: 2025-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Infants

Infants 28 days to 3 months old undergoing surgery.

Group Type EXPERIMENTAL

TetraGraph

Intervention Type DEVICE

TetraGraph 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.

Adolescents

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

Group Type ACTIVE_COMPARATOR

TetraGraph

Intervention Type DEVICE

TetraGraph 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.

Interventions

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TetraGraph

TetraGraph 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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

28 Days

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Joseph D. Tobias

OTHER

Sponsor Role lead

Responsible Party

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Joseph D. Tobias

Chief - Dept. of Anesthesiology & Pain Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Joseph D Tobias, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Central Contacts

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Julie Rice-Weimer, RN

Role: CONTACT

614-355-3142

Catherine Roth, MPH

Role: CONTACT

614-722-2997

Facility Contacts

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Julie Rice-Weimer, RN

Role: primary

614-355-3142

Other Identifiers

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STUDY00005296

Identifier Type: -

Identifier Source: org_study_id

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