SurgeryNCT07435792
TetraGraph to Evaluate Onset and Recovery Times of Rocuronium
A study testing TetraGraph in people with Surgery and Neuromuscular Blockade, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
In most clinical instances, direct laryngoscopy and endotracheal intubation is performed after a set time (generally 60 seconds) following the administration of a neuromuscular (NM) blocking agent, rocuronium. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Surgery, Neuromuscular Blockade
- What is being tested?
- TetraGraph
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2026to 31 May 2029
- Phase
- Interventional
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 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- consenting American Society of Anesthesiologists (ASA) Physical Status 1-4 patients
- undergoing a surgical procedure with general anesthesia and requiring the administration of rocuronium
Who cannot join
- 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. Contact the study team or a site near you to ask about taking part.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Train-of-four Monitoring Using the TetraGraph Electromyographic Neuromuscular Transmission Monitor to Evaluate Onset and Recovery Times of a Single Bolus Dose of Rocuronium
In most clinical instances, direct laryngoscopy and endotracheal intubation is performed after a set time (generally 60 seconds) following the administration of a neuromuscular (NM) blocking agent, rocuronium. Although the average onset time is 60 seconds, clinical studies show a standard deviation around the mean onset time of 10-20 seconds, meaning that a significant number of patients do not achieve complete NM blockade by 60 seconds. Given the above noted variability, complete NM blockade may not be achieved in 60 seconds in a significant percentage of patients, resulting in more problematic direct laryngoscopy and endotracheal intubation. Various studies have shown a higher incidence of perioperative respiratory events and postoperative concerns (sore throat, vocal cord injury) when NM blockade is not complete prior to endotracheal intubation.
This study aims to use the TetraGraph monitor to clearly identify onset times of rocuronium. Additionally, whenever feasible based on the clinical needs of the case, recovery times after the single dose of rocuronium will be recorded.
- Conditions
- Surgery, Neuromuscular Blockade
- Being tested
- TetraGraph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetraGraphDevice
A monitor that provides an electrical stimulation of the peripheral nerve and directly measures the amplitude of the evoked response of the muscles, thereby providing a quantitative and automatic measurement of muscle response to a stimulus using electromyography (EMG).
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular blockade | Experimental | Patients receiving a neuromuscular blockade with rocuronium 0.6 mg/kg. Receives: Device: TetraGraph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time
Amount of time from administration of rocuronium to the monitor reading 0 twitches.
Measured: Baseline
Secondary outcomes (1)
Recovery time
Amount of time from administration of reversal medication (sugammadex or neostigmine) to monitor reading 4 twitches.
Measured: At the completion of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start25 Aug 2026
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph D. Tobias, Nationwide Children's Hospital
- Investigators
- Joseph Tobias, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435792
- Sponsor's protocol ID
- STUDY00005738
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No