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Neuromuscular Blockade Monitor

TetraGraph for Surgery

N/A
Waitlist Available
Research Sponsored by Joseph D. Tobias
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
American Society of Anesthesiologists classification (ASA) 1-4
Patients less than 18 years of age
Must not have
Patients less than 28 days old
Patients with history of a progressive or degenerative peripheral neurologic or neuropathic disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the surgery (2-8 hrs.)
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how much rocuronium medication is needed during surgery in children under 18 years old using a device called TetraGraph Neuromuscular Transmission Monitor.

Who is the study for?
This clinical trial is for patients under 18 years old who are undergoing surgical procedures and will be monitored using the TetraGraph Neuromuscular Transmission Monitor. Specific inclusion and exclusion criteria details were not provided.
What is being tested?
The study is testing how the TetraGraph monitor affects the amount of rocuronium, a muscle relaxant, needed during surgery. It's a forward-looking study that observes participants over time without blinding.
What are the potential side effects?
Potential side effects may include typical reactions to rocuronium such as muscle weakness or paralysis persisting after surgery, breathing difficulties, changes in heart rate or blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My health is classified between ASA 1 to 4.
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I am under 18 years old.
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I am having surgery under general anesthesia and will be given rocuronium continuously.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a newborn, less than 28 days old.
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I have a history of worsening nerve disease.
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I am having surgery that does not need muscle relaxation drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the surgery (2-8 hrs.)
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the surgery (2-8 hrs.) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
EMG changes
Maximum dose of rocuronium

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Rocuronium infusionExperimental Treatment1 Intervention
Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TetraGraph
2020
N/A
~140

Find a Location

Who is running the clinical trial?

Joseph D. TobiasLead Sponsor
22 Previous Clinical Trials
3,844 Total Patients Enrolled
6 Trials studying Surgery
522 Patients Enrolled for Surgery
~67 spots leftby Dec 2025
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