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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the necessary dosage of rocuronium during surgeries using the TetraGraph Neuromuscular Transmission Monitor, a device that measures muscle response. It focuses on children undergoing surgery who require this drug for muscle relaxation. Suitable candidates for this trial are those under 18, undergoing surgery with general anesthesia, and needing continuous rocuronium.

As an unphased trial, participation offers an opportunity to contribute to important research that could enhance surgical care for children.

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 prior data suggests that the TetraGraph Neuromuscular Transmission Monitor is safe for use in surgical procedures for patients under 18?

Research has shown that TetraGraph helps doctors make better decisions and keeps patients safer during surgeries. It effectively monitors neuromuscular blockade, which prevents movement during surgery. Evidence confirms that TetraGraph aids doctors in making safer choices during operations.

Rocuronium, a drug commonly used in surgeries to relax muscles, is well-tolerated and has undergone sufficient testing to establish its safety in humans.

Overall, both TetraGraph and rocuronium are considered safe and effective for use in surgeries, providing reassurance about their safety in the operating room. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The TetraGraph device is unique because it offers a cutting-edge solution for monitoring neuromuscular function during surgeries involving rocuronium infusion. Unlike traditional methods that rely on subjective assessments, TetraGraph provides objective, quantitative data on muscle response, potentially leading to more precise dosing and improved patient safety. Researchers are excited about this technology because it could enhance the accuracy of neuromuscular blockade management, reducing the risk of complications and speeding up recovery times for patients undergoing surgery.

What evidence suggests that the TetraGraph Neuromuscular Transmission Monitor is effective for surgical procedures in patients under 18?

Research has shown that the TetraGraph Neuromuscular Transmission Monitor accurately checks muscle relaxation during surgery, surpassing the precision of other devices. In this trial, the TetraGraph system will monitor patients receiving a continuous infusion of the neuromuscular blocking agent rocuronium. The system employs train-of-four (TOF) monitoring to provide reliable feedback from the onset of muscle relaxation to recovery. This assists doctors in better controlling medications like rocuronium, which relax muscles during surgery. Overall, the TetraGraph has proven to be highly accurate, making it a trusted tool in surgical procedures. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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 am a newborn, less than 28 days old.

I have swelling due to fluid buildup.

I have a history of worsening nerve disease.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12429317/

Observational Cohort Study of TetraGraph® ... This study was conducted to evaluate the performance of the TetraGraph® EMG monitor in comparison to a widely used AMG-based device (IntelliVue ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/66/NCT05964166/Prot_001.pdf

Train-of-four monitoring using the Tetragraph® ... The primary objective of this study is to evaluate whether the sensing electrode for the novel. Tetragraph® Neuromuscular Transmission Monitor ( ...

3. senzime.com senzime.com/en/tetragraph

TetraGraph Classic Quantitative monitoring of ... TetraGraph is a state-of-the-art quantitative TOF monitor, supporting your neuromuscular blockade management with precision from induction to recovery.

4. withpower.com withpower.com/trial/phase-surgery-5-2024-6d272

TetraGraph Monitoring for Infants Undergoing Surgery The primary objective of this study is to evaluate the efficacy of train-of-four (TOF) monitoring using the TetraGraph Neuromuscular Transmission Monitor in ...

5. senzime.com senzime.com/en/press-releases/new-clinical-study-confirms-industry-leading-performance-senzimes-tetragraph-system

New clinical study confirms the industry leading ... The results confirmed the overall accuracy of the TetraGraph system and provided evidence that it is superior in accuracy to other commercially ...

6. senzime.com senzime.com/en/press-releases/new-us-data-confirms-tetragraph-supports-clinical-decisions-and-assures-patient

New US data confirms that TetraGraph supports clinical ... New US data confirms that TetraGraph supports clinical decisions and assures patient safety Recently presented abstract validates that the ...

7. senzime.com senzime.com/en/elevate-your-practice/enhancing-patient-safety-tetragraph-brief-look-asa-practice-guidelines

Enhancing patient safety with TetraGraph: A brief look into ... Enhancing patient safety with TetraGraph: A brief look into the ASA practice guidelines for neuromuscular blockade.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40944004/

Observational Cohort Study of TetraGraph ... The TetraGraph® arm was restricted during surgery. The primary outcome was the time for the TOF ratio to return to ≥90%. Secondary ...