Neuromuscular BlockadeNCT05120999
Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring
An observational study of Neuromuscular Blockade, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to use 2 devices to compare the difference in the amount of time it takes for each device to register complete muscle relaxation after the muscle relaxing medication is given. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Train of four measurement
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 14 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Qualified participants will be invited to participate in this study regardless of gender, sex, race, or religion.
Who may be able to join
- Patients willing to participate and provide an informed consent.
- Patients undergoing elective surgical procedures that require use of NMBA agents (rocuronium) 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 into the sterile field.
- Patients receiving a rapid sequence induction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring: A Prospective, Randomized Trial
The purpose of this research is to use 2 devices to compare the difference in the amount of time it takes for each device to register complete muscle relaxation after the muscle relaxing medication is given. The comparison will be made by using electromyographic (EMG), such as TetraGraph, and acceloromyographic (AMG), such as TOFScan, monitors at the time of insertion of breathing tube.
- Conditions
- Neuromuscular Blockade
- Being tested
- Train of four measurement
- Keywords
- neuromuscular blockade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Train of four measurementDevice
Use of either TetraGraph or TOFScan to measure the neuromuscular blockade
| Study group | Role | What they receive |
|---|---|---|
| Dominant hand | Application of either TetraGraph or TOFScan device on dominant hand Receives: Device: Train of four measurement | |
| Non-Dominant hand | Application of either TetraGraph or TOFScan device on non-dominant hand Receives: Device: Train of four measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time difference
Compare time difference from neuromuscular blockade agent administration to neuromuscular blockade onset
Measured: During the initiation of anesthesia period
Secondary outcomes (1)
Intubating conditions
Assess intubating conditions once a complete neuromuscular blockade has been achieved either by TetraGraph or TOFScan measurements
Measured: During the initiation of anesthesia period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start25 Oct 2021
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 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
- NCT05120999
- Sponsor's protocol ID
- 21-007425
- Status last verified
- Aug 2023
- First submitted
- 26 Oct 2021
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chaves-Cardona HE, Fouda EA, Hernandez-Torres V, Torp KD, Logvinov II, Heckman MG, Renew JR. Comparison of onset of neuromuscular blockade with electromyographic and acceleromyographic monitoring: a prospective clinical trial. Braz J Anesthesiol. 2023 Jul-Aug;73(4):393-400. doi: 10.1016/j.bjane.2023.04.004. Epub 2023 May 1.
PubMed 37137388
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring: A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT05120999
- Acronym / sponsor ID
- 21-007425
- Conditions
- Neuromuscular Blockade
- Keywords
- neuromuscular blockade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to use 2 devices to compare the difference in the amount of time it takes for each device to register complete muscle relaxation after the muscle relaxing medication is given. The comparison will be made by using electromyographic (EMG), such as TetraGraph, and acceloromyographic (AMG), such as TOFScan, monitors at the time of insertion of breathing tube.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dominant hand | – | Device: Train of four measurementApplication of either TetraGraph or TOFScan device on dominant hand |
| Non-Dominant hand | – | Device: Train of four measurementApplication of either TetraGraph or TOFScan device on non-dominant hand |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Qualified participants will be invited to participate in this study regardless of gender, sex, race, or religion.
Key inclusion criteria (2 listed)
- Patients willing to participate and provide an informed consent.
- Patients undergoing elective surgical procedures that require use of NMBA agents (rocuronium) administered intraoperatively.
Key exclusion criteria (5 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 into the sterile field.
- Patients receiving a rapid sequence induction.
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 |
|---|---|---|
| Train of four measurementUse of either TetraGraph or TOFScan to measure the neuromuscular blockade | Device | Dominant hand, Non-Dominant hand |
Primary outcome
Time difference
Time frame: During the initiation of anesthesia period
Compare time difference from neuromuscular blockade agent administration to neuromuscular blockade onset
1 secondary outcome
Intubating conditions
Time frame: During the initiation of anesthesia period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Derived from this study: PubMed 37137388Chaves-Cardona HE, Fouda EA, Hernandez-Torres V, Torp KD, Logvinov II, Heckman MG, Renew JR. Comparison of onset of neuromuscular blockade with electromyographic and acceleromyographic monitoring: a prospective clinical trial. Braz J Anesthesiol. 2023 Jul-Aug;73(4):393-400. doi: 10.1016/j.bjane.2023.04.004. Epub 2023 May 1.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blockade, run by Mayo Clinic 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 2 inclusion and 5 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 8 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time difference (time frame: During the initiation of anesthesia period). 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 NCT05120999, 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 8 Aug 2023.