TetraGraph Monitoring for Infants Undergoing Surgery

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Joseph D. Tobias

Must be taking: NMBAs

Disqualifiers: Under 28 days, Neurologic disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: During the surgery

100 Participants Needed

Trial Summary

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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the TetraGraph (TM) NMT Monitor treatment for infants undergoing surgery?

The research highlights the importance of accurate and reliable monitoring during surgery, which can improve patient outcomes by guiding therapy and reducing risks. Although specific data on the TetraGraph (TM) NMT Monitor is not provided, the general effectiveness of advanced monitoring technologies in improving surgical outcomes is supported by the studies. ^{1 2 3 4 5}

Is TetraGraph Monitoring safe for infants undergoing surgery?

The available research does not specifically address the safety of TetraGraph Monitoring for infants undergoing surgery, but it highlights general concerns about sedation and anesthesia in children, such as the risk of neurotoxicity and respiratory issues. Continuous monitoring and advancements in technology have improved safety during sedation, but specific data on TetraGraph Monitoring is not provided. ^{6 7 8 9 10}

How is the TetraGraph Monitoring treatment different from other treatments for infants undergoing surgery?

The TetraGraph Monitoring treatment is unique because it specifically monitors neuromuscular transmission (NMT) in infants during surgery, which helps ensure proper muscle relaxation and recovery. This is different from other treatments that focus on sedation or anesthesia without specialized monitoring of neuromuscular function. ^{11 12 13 14 15}

What is the purpose of this trial?

The primary objective of this study is to evaluate the efficacy of train-of-four (TOF) monitoring using the TetraGraph Neuromuscular Transmission Monitor in pediatric patients less than 1 year of age and when feasible to compare it to standard TOF monitoring using a qualitative monitor.

Eligibility Criteria

This trial is for infants under 1 year old who are undergoing surgery. The study aims to include those who can safely undergo neuromuscular transmission monitoring during their procedure.

Inclusion Criteria

I am 1 year old or younger.

I am having surgery that needs general anesthesia and muscle relaxants.

My health is stable enough for surgery.

Exclusion Criteria

Edematous patients

I am a newborn, less than 28 days old.

I have a history of nerve disorders.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo train-of-four (TOF) monitoring using the TetraGraph Neuromuscular Transmission Monitor during surgery

During the surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TetraGraph (TM) NMT Monitor

Trial Overview The trial is testing the effectiveness of a device called TetraGraph in monitoring muscle response, known as train-of-four (TOF), during surgery in infants compared to standard TOF monitors when possible.

Participant Groups

Group I: TetraGraph (TM) NMT Monitor Experimental Treatment 1 Intervention

TetraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.

Who Is Running the Clinical Trial?

Joseph D. Tobias

Lead Sponsor

Trials

24

Recruited

4,000+

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Application of Narcotrend® monitor for evaluation of depth of anesthesia in infants undergoing cardiac surgery: a prospective control study. [2015]

2. Italy pubmed.ncbi.nlm.nih.gov

[Monitoring in pediatric anesthesia]. [2007]

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

Intraoperative monitoring during vascular surgery. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Monitoring in neuroanaesthesia: update of clinical usefulness. [2019]

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

Neuroanesthesia. Innovative techniques and monitoring. [2019]

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

Pediatric Sedation: Using Secondary Data to Describe Registered Nurse Practice in Radiology. [2020]

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

Anesthetic-Related Neurotoxicity and Neuroimaging in Children: A Call for Conversation. [2018]

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

Risks of propofol sedation/anesthesia for imaging studies in pediatric research: eight years of experience in a clinical research center. [2021]

9. France pubmed.ncbi.nlm.nih.gov

The 'dark' side of sedation: 12 years of office-based pediatric deep sedation for electroretinography in the dark. [2013]

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

Microstream capnography improves patient monitoring during moderate sedation: a randomized, controlled trial. [2022]

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

Intravenously administered pentobarbital sodium for sedation in pediatric CT. [2013]

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

Brief report: methods for acquiring structural MRI data in very young children with autism without the use of sedation. [2019]

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

Sedation, anesthesia, and physiologic monitoring during MR imaging: evaluation of procedures and equipment. [2019]

14. China pubmed.ncbi.nlm.nih.gov

[Sedative effect of intranasal midazolam in neonates undergoing magnetic resonance imaging: a prospective single-blind randomized controlled study]. [2020]

15. Germany pubmed.ncbi.nlm.nih.gov

[Medication and monitoring in young pediatric patients in NMR (nuclear magnetic resonance) studies]. [2013]