Residual Neuromuscular BlockadeNCT04352140
Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting
A study testing Tetragraph and ToFscan in people with Residual Neuromuscular Blockade, run by Mayo Clinic at 3 sites in 3 countries.
Trial summary
Researchers are comparing the ease of use and repeatability of the force vs electrical activity produced by a muscle after it has undergone nerve stimulation during a surgical procedure in which the patients' arm movement is restricted (placed under surgical drapes) in laparoscopic or robotic procedures. 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 and ToFscan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 18 Aug 2020to 14 Feb 2022
- 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 laparoscopic or robotic surgical procedure that requires use of NMBA agents administered intraoperatively.
Who cannot join
- Patients with 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.
- Patients having surgery that would involve prepping the arm or leg into the sterile field
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting. A Prospective, Randomized Trial.
Researchers are comparing the ease of use and repeatability of the force vs electrical activity produced by a muscle after it has undergone nerve stimulation during a surgical procedure in which the patients' arm movement is restricted (placed under surgical drapes) in laparoscopic or robotic procedures.
- Conditions
- Residual Neuromuscular Blockade
- Being tested
- Tetragraph, ToFscan
- Keywords
- Neuromuscular Blockade, 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.
TetragraphDevice
FDA approved neuromuscular transmission monitor capable of measuring 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 electrical neurostimulation via skin electrodes.
ToFscanDevice
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 |
|---|---|---|
| Dominant hand | Experimental | Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand, ToFscan placed on non-dominant hand Receives: Device: Tetragraph; Device: ToFscan |
| Non-dominant hand | Experimental | Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the non-dominant hand, ToFscan placed on dominant hand Receives: Device: Tetragraph; Device: ToFscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Values Between Tetragraph and ToFscan
The number of subject's who's residual neuromuscular blockage units are the same on both the TetraGraph and the ToFscan
Measured: Up to 1 hour postoperatively
Secondary outcomes (1)
Incidence of Residual Neuromuscular Blockade
Number of patients with train of four ratio < 0.9 after administration of reversal agent.
Measured: Up to 1 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start18 Aug 2020
- Primary completion14 Feb 2022
- Study completion14 Feb 2022
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT04352140
- Sponsor's protocol ID
- 20-000629
- Status last verified
- Jan 2023
- First submitted
- 16 Apr 2020
- Last updated
- 17 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting. A Prospective, Randomized Trial.
- ClinicalTrials.gov ID
- NCT04352140
- Acronym / sponsor ID
- 20-000629
- Conditions
- Residual Neuromuscular Blockade
- Keywords
- Neuromuscular Blockade, Tetragraph, AMG, EMG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Posted 17 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are comparing the ease of use and repeatability of the force vs electrical activity produced by a muscle after it has undergone nerve stimulation during a surgical procedure in which the patients' arm movement is restricted (placed under surgical drapes) in laparoscopic or robotic procedures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dominant hand | Experimental | Device: Tetragraph, Device: ToFscanSubject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand, ToFscan placed on non-dominant hand |
| Non-dominant hand | Experimental | Device: Tetragraph, Device: ToFscanSubject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the non-dominant hand, ToFscan placed on 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 laparoscopic or robotic surgical procedure that requires use of NMBA agents administered intraoperatively.
Key exclusion criteria (4 listed)
- Patients with 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.
- Patients having surgery that would involve prepping the arm or leg into the sterile field
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 |
|---|---|---|
| TetragraphFDA approved neuromuscular transmission monitor capable of measuring 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 electrical neurostimulation via skin electrodes. | Device | Dominant hand, Non-dominant hand |
| ToFscanToFscan 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 | Dominant hand, Non-dominant hand |
Primary outcome
Accuracy of Values Between Tetragraph and ToFscan
Time frame: Up to 1 hour postoperatively
The number of subject's who's residual neuromuscular blockage units are the same on both the TetraGraph and the ToFscan
1 secondary outcome
Incidence of Residual Neuromuscular Blockade
Time frame: Up to 1 hour postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetragraph and ToFscan in people with Residual Neuromuscular Blockade, run by Mayo Clinic at 3 sites in 3 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 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 17 Feb 2023. 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, France, 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 17 Feb 2023). 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?
Accuracy of Values Between Tetragraph and ToFscan (time frame: Up to 1 hour postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2023.