TOF Monitoring Using the TetraGraph in Patients Less Than 1 Year of Age

N/AActive Not RecruitingNCT06458023

Joseph D. Tobias50 enrolled

Overview

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 and when feasible to compare it to standard TOF monitoring using a qualitative monitor.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Surgery

Interventions

TetraGraph (TM) NMT MonitorDEVICE

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.

Eligibility

Sex: ALLMin age: 1 MonthMax age: 12 Months

Medical Language ↔ Plain English

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

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

EMG changes

Changes in the amplitude of the evoked response of the muscles.

Time frame: During the surgery

Data from ClinicalTrials.gov

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