TetraGraph for Surgery

Overseen By Catherine Roth, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Joseph D. Tobias

Must be taking: Rocuronium

Disqualifiers: Neurologic disorders, Edema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2-8 hours

100 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the purpose of this trial?

This is a prospective, non-blinded study to evaluate rocuronium infusion requirements using the TetraGraph Neuromuscular Transmission Monitor during surgical procedures in patients less than 18 yrs. of age.

Eligibility Criteria

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.

Inclusion Criteria

My health is classified between ASA 1 to 4.

I am under 18 years old.

I am having surgery under general anesthesia and will be given rocuronium continuously.

Exclusion Criteria

I have swelling due to fluid buildup.

I am a newborn, less than 28 days old.

I have a history of worsening nerve disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rocuronium infusion during surgical procedures while being monitored using the TetraGraph Neuromuscular Transmission Monitor

2-8 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TetraGraph

Trial Overview 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.

Participant Groups

Group I: Rocuronium infusion Experimental Treatment 1 Intervention

Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium.

Who Is Running the Clinical Trial?

Joseph D. Tobias

Lead Sponsor

Trials

24

Recruited

4,000+