TetraGraph Monitoring for Neuromuscular Blockade Recovery

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Stroke, Myasthenia gravis, Severe renal impairment, others

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

Compensation: Varies

Number of Visits: 2

Duration: Intraoperative

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how quickly a new device, TetraGraph, can monitor muscle recovery after surgery. It targets individuals undergoing surgery that requires muscle relaxants and a special heart monitoring device. The trial aims to understand the connection between muscle recovery time and heart function. Suitable participants have no nerve or muscle disorders and are scheduled for elective surgery needing specific muscle relaxants and heart monitoring. As an unphased trial, this study offers a unique opportunity to contribute to advancements in surgical recovery monitoring.

Will I have to stop taking my current medications?

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 device is safe for monitoring neuromuscular blockade recovery?

Research shows that TetraGraph monitors muscle relaxation during surgery. Studies have demonstrated that it keeps patients safe by accurately measuring muscle relaxation and recovery speed, aiding doctors in making better surgical decisions.

Evidence confirms that TetraGraph is safe and effective for patient monitoring, comparable to other similar tools. It has been used extensively and is trusted for its accuracy. Additionally, the FDA has approved the technology, indicating it has passed important safety checks for monitoring muscle relaxation during surgery.

Overall, TetraGraph is well-tolerated by patients, with no major safety issues reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TetraGraph monitoring system because it offers a new way to track neuromuscular blockade recovery during surgery. Unlike traditional methods that often rely on subjective assessments of muscle function, TetraGraph provides objective, real-time data through a device placed on the hand. This precise monitoring could lead to more accurate dosing of neuromuscular blocking agents, reducing the risk of complications and improving patient outcomes. By enhancing the accuracy of neuromuscular recovery assessment, TetraGraph has the potential to transform how anesthesiologists manage muscle relaxants during surgery.

What evidence suggests that the TetraGraph device is effective for monitoring neuromuscular blockade recovery?

Research has shown that TetraGraph, which participants in this trial will use, effectively monitors muscle relaxation and recovery during surgeries. One study found that it accurately measures the time muscles take to return to normal function. It employs electromyography (EMG) to track muscle signals, aiding doctors in assessing muscle recovery. This tool is valuable because it provides precise information from the onset of muscle relaxation to full recovery. Comparisons with other standard devices have demonstrated TetraGraph's effectiveness in monitoring muscle recovery. These findings support its usefulness in managing muscle relaxation during surgeries. ^{3 4 6 7 8}

Who Is on the Research Team?

J.Ross Renew, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having elective surgery needing muscle relaxation with rocuronium and a heart monitor (pulmonary artery catheter). They must be willing to consent. It's not for those with severe kidney or liver disease, surgeries involving an arm or leg in the sterile field, or people with conditions like stroke, nerve damage, Dupuytren contracture, or myasthenia gravis.

Inclusion Criteria

I am willing to join the study and can give my consent.

I am scheduled for surgery that will use rocuronium and monitor my heart with a special catheter.

Exclusion Criteria

You have a condition called myasthenia gravis, which affects your muscles and nerves.

My surgery will require sterilizing my arm or leg.

I do not have severe kidney or end-stage liver disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo elective surgical procedures with TetraGraph monitoring and administration of sugammadex for reversal of rocuronium-induced blockade

Intraoperative

1 visit (in-person)

Follow-up

Participants are monitored for recovery time and correlation with cardiac output postoperatively

Up to 1 hour postoperative

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• TetraGraph

Trial Overview The study is testing TetraGraph to see how quickly patients recover from muscle relaxants used during surgery and how this recovery time relates to their heart function. The goal is to better understand the link between cardiac output and emergence from anesthesia.

How Is the Trial Designed?

Group I: TetraGraph monitoring Experimental Treatment 1 Intervention

Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on either hand at a discretion of the anesthesiologist

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

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

Observational Cohort Study of TetraGraph® ... The primary outcome was the time required for recovery to a TOF ratio of at least 90% following neuromuscular blockade. Secondary outcomes ...

2. 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12479079/

Quantitative Train-of-Four Monitoring Using the TetraGraph ... Here we present the use of an electromyography (EMG)-based TOF monitor in a 9-year-old boy with end-stage renal disease during intraoperative ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/pan.70043

Intraoperative Electromyographic Monitoring in Children ... Recovery from neuromuscular block ... Complete data of neuromuscular recording (baseline to recovery) was obtained in 36 patients.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06792058

NCT06792058 | Comparative Study of TetraGraph and ... This study compares the performance of the electromyography (EMG)-based Tetragraph neuromuscular monitor with the gold standard mechanomyography (MMG) device, ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K220530.pdf

K220530 - Elisa Maldonado-Holmertz - accessdata.fda.gov Thus, the test data demonstrate that TetraGraph is at least as safe and effective in monitoring the relaxation of the patient when neuromuscular ...

7. 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 ...

8. 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 ... Monitoring the depth of neuromuscular blockade is vital to ensure patient safety during anesthesia. This also applies to pediatric patients ...