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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to determine the time it takes to reverse the effects of the intraoperative medication given to relax the muscles and how this period of recovery correlates with a function of the heart.

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 data supports the effectiveness of the treatment TetraGraph for neuromuscular blockade recovery?

The TetraGraph is an electromyography-based device that has been shown to effectively monitor neuromuscular blockade recovery, providing reliable measurements similar to other established devices like TOFscan. This suggests it is a useful tool for ensuring patients recover properly from muscle relaxants used during surgery. ^{1 2 3 4 5}

Is TetraGraph monitoring safe for humans?

The available research does not specifically address the safety of TetraGraph monitoring, but it is used in clinical settings for monitoring neuromuscular recovery, suggesting it is generally considered safe for this purpose. ^{2 3 5 6 7}

How does TetraGraph Monitoring for Neuromuscular Blockade Recovery differ from other treatments?

TetraGraph Monitoring is unique because it provides real-time, objective data on neuromuscular function, which helps in accurately assessing the recovery from neuromuscular blockade. This is different from traditional methods that may rely on subjective assessments or less precise monitoring tools. ^{8 9 10 11 12}

Research Team

J.Ross Renew, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient and Care Delivery Characteristics Associated With Harm From Neuromuscular Blockade. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of the TetraGraph and TOFscan for monitoring recovery from neuromuscular blockade in the Post Anesthesia Care Unit. [2021]

3. France pubmed.ncbi.nlm.nih.gov

Comparison of two electromyography-based neuromuscular monitors, AF-201P and TetraGraph, in rocuronium-induced neuromuscular block: A prospective comparative study. [2022]

4. Brazil pubmed.ncbi.nlm.nih.gov

Comparison of onset of neuromuscular blockade with electromyographic and acceleromyographic monitoring: a prospective clinical trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A comparison of accelerometric monitoring by TOF Watch® SX and electromyographic monitoring by Tetragraph® for recovery from neuromuscular blockade. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Preventing errors with neuromuscular blocking agents. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Ipsilateral and Simultaneous Comparison of Responses from Acceleromyography- and Electromyography-based Neuromuscular Monitors. [2021]

8. Japan pubmed.ncbi.nlm.nih.gov

Efficiency of the TOF-Cuff™ for the evaluation of rocuronium-induced neuromuscular block and its reversal with sugammadex: a comparative study vs. acceleromyography. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Complications of radiologic contrast in patients with myasthenia gravis. [2016]

10. Australia pubmed.ncbi.nlm.nih.gov

Myelography with metrizamide--an analysis of the complications encountered in cervical, thoracic and lumbar myelography. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Myasthenia Gravis following Low-Osmolality Iodinated Contrast Media. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Metrizamide myelography. [2015]