SurgeryNCT06472284

TetraGraph in Rocuronium Infusions

A study testing TetraGraph in people with Surgery, run by Joseph D. Tobias at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 28 days to 18 years
Conditions the study is for: Surgery
What is being tested?: TetraGraph
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 12 Sep 2024to 24 Apr 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 28 days to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Patients less than 18 years of age
American Society of Anesthesiologists classification (ASA) 1-4
Patients undergoing a surgical procedure with general anesthesia and requiring the continuous administration of rocuroniuim

Who cannot join

Patients less than 28 days old
Patients with history of a progressive or degenerative peripheral neurologic or neuropathic disorder
Patients undergoing a surgical procedure in which neuromuscular blockade is not required
Edematous patients

Trial locations and contacts

1 site in 1 country.

United States1 site

Nationwide Children's Hospital
Columbus, Ohio, 43205

Other trials in United States

About this study

Official title: Train-of-four Monitoring Using the TetraGraph Neuromuscular Transmission Monitor to Evaluate Rocuronium Infusion Requirements During Major Neurosurgical and Surgical Procedures

Conditions: Surgery
Being tested: TetraGraph

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TetraGraphDevice
etraGraph 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.

Study groups in NCT06472284
Study group	Role	What they receive
Rocuronium infusion	Experimental	Patients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium. Receives: Device: TetraGraph

What is being measured

The primary outcome is the main question the study is designed to answer.

Rocuronium Bolus Dose
Amount of rocuronium administered in a bolus dose during induction of anesthesia.
Measured: During the surgery (2-8 hrs.)
Rocuronium Infusion Dose
The amount of rocuronium given by continuous infusion in mg/kg/hr to maintain one twitch of the train of four (TOF)
Measured: During surgery (2-8 hrs.)
Maximum Dose of Rocuronium
The maximum dose of rocuronium administered by a continuous infusion per patient to maintain one twitch of the train of four (TOF)
Measured: During the surgery (2-8 hrs.)

Secondary outcomes (4)

Rocuronium Infusion Time
Amount of time in minutes that patients received rocuronium infusion.
Measured: During the surgery (2-8 hrs.)
Rocuronium Rescue Boluses
The number of patient that received rescue boluses of rocuronium in addition to the infusion to maintain one twitch of the train of four (TOF)
Measured: During the surgery (2-8 hrs.)
Anesthesia Time
The total amount of time patients were under anesthesia care in minutes.
Measured: During the surgery (2-8 hrs.)
Surgical Time
The total amount of time from first incision to closure in minutes.
Measured: During the surgery (2-8 hrs.)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Sep 202424 Apr 2025

First posted25 Jun 2024
Study start12 Sep 2024
Primary completion24 Apr 2025
Study completion24 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06472284
Sponsor's protocol ID: STUDY00004154
Status last verified: Jan 2026
First submitted: 19 Jun 2024
Last updated: 13 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Train-of-four Monitoring Using the TetraGraph Neuromuscular Transmission Monitor to Evaluate Rocuronium Infusion Requirements During Major Neurosurgical and Surgical Procedures
ClinicalTrials.gov ID: NCT06472284
Acronym / sponsor ID: STUDY00004154
Conditions: Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Joseph D. TobiasUniversity, hospital or other
Study start: 12 Sep 2024 (actual)
Primary completion: 24 Apr 2025 (actual)
Study completion: 24 Apr 2025 (actual)
First posted: 25 Jun 2024 (actual)
Results: Posted 13 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Rocuronium infusion	Experimental	Device: TetraGraphPatients who are scheduled for elective, urgent or emergent surgery requiring the continuous infusion of the neuromuscular blocking agent, rocuronium.

Who may qualify

Ages: 28 days to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Patients less than 18 years of age
American Society of Anesthesiologists classification (ASA) 1-4
Patients undergoing a surgical procedure with general anesthesia and requiring the continuous administration of rocuroniuim

Key exclusion criteria (4 listed)

Patients less than 28 days old
Patients with history of a progressive or degenerative peripheral neurologic or neuropathic disorder
Patients undergoing a surgical procedure in which neuromuscular blockade is not required
Edematous patients

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TetraGraphetraGraph 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.	Device	Rocuronium infusion

Primary outcome

Rocuronium Bolus Dose
Time frame: During the surgery (2-8 hrs.)
Amount of rocuronium administered in a bolus dose during induction of anesthesia.
Rocuronium Infusion Dose
Time frame: During surgery (2-8 hrs.)
The amount of rocuronium given by continuous infusion in mg/kg/hr to maintain one twitch of the train of four (TOF)
Maximum Dose of Rocuronium
Time frame: During the surgery (2-8 hrs.)
The maximum dose of rocuronium administered by a continuous infusion per patient to maintain one twitch of the train of four (TOF)

4 secondary outcomes

Rocuronium Infusion Time
Time frame: During the surgery (2-8 hrs.)
Rocuronium Rescue Boluses
Time frame: During the surgery (2-8 hrs.)
Anesthesia Time
Time frame: During the surgery (2-8 hrs.)
Surgical Time
Time frame: During the surgery (2-8 hrs.)

Results and safety

Results posted to the registry on 13 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rocuronium Infusion	50	48

Primary outcome: Rocuronium Bolus Dose

Time frame: During the surgery (2-8 hrs.). Median (Inter-Quartile Range). Unit: mg/kg

Measure	Rocuronium Infusion n = 48
Value	0.8 (0.7 to 1.1)

Primary outcome: Rocuronium Infusion Dose

Time frame: During surgery (2-8 hrs.). Median (Inter-Quartile Range). Unit: mg/kg/hr

Measure	Rocuronium Infusion n = 48
Value	0.48 (0.36 to 0.6)

Primary outcome: Maximum Dose of Rocuronium

Time frame: During the surgery (2-8 hrs.). Count of participants. Unit: Participants

Measure	Rocuronium Infusion n = 48
0.1 to <0.4 mg/kg/hr	1
0.4 to 0.6 mg/kg/hr	41
>0.6 to 0.72 mg/kg/hr	6

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 Day (day of surgery). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rocuronium Infusion	0 of 48 (0%)	0 of 48 (0%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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RecruitingPhase 4
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Enrolling by invitation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TetraGraph in people with Surgery, run by Joseph D. Tobias at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rocuronium Bolus Dose (time frame: During the surgery (2-8 hrs.)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06472284.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.