Residual Neuromuscular BlockadeNCT03920670
Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
A study testing TetraGraph (TG) and ToFscan (TS) in people with Residual Neuromuscular Blockade, run by Mayo Clinic at 3 sites in 2 countries.
Trial summary
The aim of this investigation is to compare the performance of two quantitative monitors utilized on post-anesthesia recovering patients. The ToFscan (Draeger Medical Inc., Telford, PA) represents one of the few standalone acceleromyography (AMG)-based quantitative monitors available for routine clinical use in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Residual Neuromuscular Blockade
- What is being tested?
- TetraGraph (TG) and ToFscan (TS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 28 Feb 2019to 30 Nov 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or = 18 years old
- Patients willing to participate and provide an informed consent
- Patients undergoing an elective surgical procedure that requires use of non-depolarizing NMBA agents administered intraoperatively.
Who cannot join
- Patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
- Patients with systemic neuromuscular diseases such as myasthenia gravis
- Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
NorthShore University HealthSystem
Evanston, Illinois, 60201
Mayo Clinic in Florida
Jacksonville, Florida, 32224
About this study
The aim of this investigation is to compare the performance of two quantitative monitors utilized on post-anesthesia recovering patients. The ToFscan (Draeger Medical Inc., Telford, PA) represents one of the few standalone acceleromyography (AMG)-based quantitative monitors available for routine clinical use in the United States. The TetraGraph (Senzime AB, Uppsala, Sweden) is a standalone electromyography (EMG)-based quantitative monitor that recently received Conformité Européene (CE) approval. While both of these quantitative monitors can be utilized to guide intraoperative NMBA re-dosing and confirm recovery, they provide their objective data via drastically different techniques.
- Conditions
- Residual Neuromuscular Blockade
- Being tested
- TetraGraph (TG), ToFscan (TS)
- Keywords
- Neuromuscular Blockade, ToFscan, Tetragraph, AMG, EMG
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetraGraph (TG)Device
TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.
ToFscan (TS)Device
ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three-dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Tetragraph (TG) | Experimental | TetraGraph placed on dominant hand, ToFscan placed on non-dominant hand Receives: Device: TetraGraph (TG); Device: ToFscan (TS) |
| ToFscan (TS) | Active comparator | ToFscan placed on dominant hand, TetraGraph (TG) placed on non-dominant hand Receives: Device: TetraGraph (TG); Device: ToFscan (TS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Train-of-Four Ratios (TOFR's)
Train-of-four ratios is the ratio of the fourth muscle response to the first one.
Measured: baseline, after 5 minutes, after + 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start28 Feb 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Residual Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Ross Renew, M.D., Mayo Clinic
- Investigators
- J Ross Renew, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920670
- Sponsor's protocol ID
- 18-011298
- Status last verified
- Mar 2021
- First submitted
- 13 Feb 2019
- Last updated
- 29 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur M, Benson J, Newmark RL, Maher CE. Comparison of the TOFscan and the TOF-Watch SX during Recovery of Neuromuscular Function. Anesthesiology. 2018 Nov;129(5):880-888. doi: 10.1097/ALN.0000000000002400.
PubMed 30130260
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
- ClinicalTrials.gov ID
- NCT03920670
- Acronym / sponsor ID
- 18-011298
- Conditions
- Residual Neuromuscular Blockade
- Keywords
- Neuromuscular Blockade, ToFscan, Tetragraph, AMG, EMG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Posted 29 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this investigation is to compare the performance of two quantitative monitors utilized on post-anesthesia recovering patients. The ToFscan (Draeger Medical Inc., Telford, PA) represents one of the few standalone acceleromyography (AMG)-based quantitative monitors available for routine clinical use in the United States. The TetraGraph (Senzime AB, Uppsala, Sweden) is a standalone electromyography (EMG)-based quantitative monitor that recently received Conformité Européene (CE) approval. While both of these quantitative monitors can be utilized to guide intraoperative NMBA re-dosing and confirm recovery, they provide their objective data via drastically different techniques.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetragraph (TG) | Experimental | Device: TetraGraph (TG), Device: ToFscan (TS)TetraGraph placed on dominant hand, ToFscan placed on non-dominant hand |
| ToFscan (TS) | Active comparator | Device: TetraGraph (TG), Device: ToFscan (TS)ToFscan placed on dominant hand, TetraGraph (TG) placed on non-dominant hand |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > or = 18 years old
- Patients willing to participate and provide an informed consent
- Patients undergoing an elective surgical procedure that requires use of non-depolarizing NMBA agents administered intraoperatively.
Key exclusion criteria (3 listed)
- Patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
- Patients with systemic neuromuscular diseases such as myasthenia gravis
- Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
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 |
|---|---|---|
| TetraGraph (TG)TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured. | Device | Tetragraph (TG), ToFscan (TS) |
| ToFscan (TS)ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three-dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured. | Device | Tetragraph (TG), ToFscan (TS) |
Primary outcome
Mean Train-of-Four Ratios (TOFR's)
Time frame: baseline, after 5 minutes, after + 10 minutes
Train-of-four ratios is the ratio of the fourth muscle response to the first one.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30130260Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur M, Benson J, Newmark RL, Maher CE. Comparison of the TOFscan and the TOF-Watch SX during Recovery of Neuromuscular Function. Anesthesiology. 2018 Nov;129(5):880-888. doi: 10.1097/ALN.0000000000002400.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
J Ross Renew, MD principal investigator
Mayo Clinic
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TetraGraph (TG) and ToFscan (TS) in people with Residual Neuromuscular Blockade, run by Mayo Clinic at 3 sites in 2 countries.
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 3 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 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Hungary. 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 29 Apr 2021). 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?
Mean Train-of-Four Ratios (TOFR's) (time frame: baseline, after 5 minutes, after + 10 minutes). 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 NCT03920670, which also lists 1 linked publication.
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 29 Apr 2021.