Neuromuscular BlockadeNCT04845386
: A Comparison of Neuromuscular Transmission in the Muscles During General Anesthesia
An observational study of Neuromuscular Blockade, run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.
Trial summary
The investigators want to compare new muscle relaxation monitoring, TOF-Cuff and TOF-Scan, during general anesthesia. Standard monitoring is using thumb, however it can't be use on every patient. Alternative can be eyebrow muscle or foot muscle. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- TOF Cuff on arm, TOF Cuff on lower leg and TOF Scan on toe
- Type of treatment
- Medical device
- How many people
- 128 participants
- Where
- 1 sitePoland
- Study dates
- 25 Mar 2021to 30 Jun 2021
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In the study will take patients qualified to the elective surgery
Who may be able to join
- Age 18-75
- ASA classification I,II,III
- Elective surgery
- BMI(body mass index) 17-35
- Surgery in the supine position
- Informed consent of the patient
Who cannot join
- Pregnancy and breastfeeding
- Urgent indications for surgery
- ASA classification >III
- Neuromuscular diseases
- Polyneuropathy
- Diabetes
Show all 9Show fewer
- Drug addiction
- Family history of malignant hyperthermia
- Allergic to propofol, fentanyl or mivacurium
Trial locations and contacts
1 site in 1 country.
Poland1 site
Anesthesiology and Intensive Care Clinical Ward, Regional Specialized Hospital
Olsztyn, Warmian-Masurian Voivodeship, 10-561
About this study
Official title: A Comparison of Neuromuscular Transmission in the Arm and Hand Muscles With Alternative Muscles Such as the Lower Leg Muscles and the Corrugator Supercilii During General Anesthesia
The investigators want to compare new muscle relaxation monitoring, TOF-Cuff and TOF-Scan, during general anesthesia. Standard monitoring is using thumb, however it can't be use on every patient. Alternative can be eyebrow muscle or foot muscle.
There is only few old study that compares this muscle and used mivacurium. The study aims to compare TOF-Cuff and TOF-Scan with different sensor and use mivacurium.
Read the detailed description
In our research in addition to the standard intraoperative monitoring, which includes the assessment of ECG and saturation, the investigators would like to estimate muscle relaxation by using two different methods: a TOF-Cuff which additionally allows to measure inoperative blood pressure and TOF-Scan with different sensor. Our aim is to compare two different methods of muscle relaxation monitoring in patients who will administer muscle relaxant - mivacurium. After receiving painkillers and hypnotics, when the patient is falling asleep, the standard dose of mivacurium 0.2 mg / kg body weight will be administered. Then, painless simultaneous stimulation with TOF-Cuff and TOF-Scan devices will begin. Until intubation, measurements will be made in every 30 seconds and then every 5 minutes until extubation. Extubation will take place according to the guidelines when the TOF-Cuff measurement on the arm is greater than 0.9 - this is the value at which the patient is considered ready to start breathing on his own. The following will be documented: the initiation of drug administration, intubation, possible repeated doses of mivacurium 2 mg, antagonization, extubation, possible side effects (e.g., transient cardiac disturbances, reddening of the skin, lowering blood pressure, bronchospasm, erythema, urticaria) and technical problems.
- Conditions
- Neuromuscular Blockade
- Being tested
- TOF Cuff on arm, TOF Cuff on lower leg, TOF Scan on toe, TOF Scan on adductor pollicis, TOF Scan on corrugator supercilii
- Keywords
- TOF Cuff, TOF Scan, Neuromuscular transmission, corrugator supercilii, Mivacurium, adductor pollicis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOF Cuff on armDevice
The TOF Cuff will be installed on one arm in opposite of TOF Scan. After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block.
TOF Cuff on lower legDevice
The TOF Cuff will be installed on one lower leg. After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block.
TOF Scan on toeDevice
The TOF Scan will be installed on hallux . After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block.
TOF Scan on adductor pollicisDevice
The TOF Scan will be installed on Thumb. After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block.
TOF Scan on corrugator superciliiDevice
The TOF Scan will be installed on corrugator supercilii. After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block.
| Study group | Role | What they receive |
|---|---|---|
| TOF Cuff on arm and TOF Scan on corrugator supercilii | Patients undergoing surgery with intubation and receiving a intubation dose of mivacurium (0.2 mg/kg) and repeated dose of mivacurium (2mg) depending of needing under, routine gas anesthesia will have monitoring of neuromuscular block with two monitors simultaneously. Receives: Device: TOF Cuff on arm; Device: TOF Scan on corrugator supercilii | |
| TOF Cuff on lower leg and TOF Scan on adductor pollicis | Patients undergoing surgery with intubation and receiving a intubation dose of mivacurium (0.2 mg/kg) and repeated dose of mivacurium (2mg) depending of needing under, routine gas anesthesia will have monitoring of neuromuscular block with two monitors simultaneously. Receives: Device: TOF Cuff on lower leg; Device: TOF Scan on adductor pollicis | |
| TOF Scan on adductor pollicis and TOF Scan on toe | Patients undergoing surgery with intubation and receiving a intubation dose of mivacurium (0.2 mg/kg) and repeated dose of mivacurium (2mg) depending of needing under, routine gas anesthesia will have monitoring of neuromuscular block with two monitors simultaneously. Receives: Device: TOF Scan on toe; Device: TOF Scan on adductor pollicis | |
| TOF Scan on adductor pollicis and TOF Cuff on arm | Patients undergoing surgery with intubation and receiving a intubation dose of mivacurium (0.2 mg/kg) and repeated dose of mivacurium (2mg) depending of needing under, routine gas anesthesia will have monitoring of neuromuscular block with two monitors simultaneously. Receives: Device: TOF Cuff on arm; Device: TOF Scan on adductor pollicis | |
| TOF Scan on adductor pollicis and TOF Scan on corrugator supercilii | Patients undergoing surgery with intubation and receiving a intubation dose of mivacurium (0.2 mg/kg) and repeated dose of mivacurium (2mg) depending of needing under, routine gas anesthesia will have monitoring of neuromuscular block with two monitors simultaneously. Receives: Device: TOF Scan on adductor pollicis; Device: TOF Scan on corrugator supercilii |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time
Time in seconds from start of injection of mivacurium until emergence of TOF ratio of 0%. TOF = Train of Four
Measured: 1 to 10 minutes
Total recovery time of neuromuscular block
The total recovery time, i.e. total duration of the neuromuscular block is defined as the time in minutes from start of injection of mivacurium until a normalized TOF ratio of 90%
Measured: 30 to 500 minutes
Secondary outcomes (1)
Time to repeated dose
Time in minuted from TOF ratio 0% to repeated dose
Measured: 5 to 200 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start25 Mar 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
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.
- 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Warmia and Mazury in Olsztyn
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Specialized Hospital in Olsztyn
- Responsible party
- Principal investigator, Radkowski Paweł MD PhD, University of Warmia and Mazury in Olsztyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845386
- Sponsor's protocol ID
- Mivacron 2021
- Status last verified
- May 2022
- First submitted
- 9 Apr 2021
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Radkowski P, Rusc J, Keska M, Onichimowski D. Comparison of TOF scan neuromuscular monitoring on adductor pollicis vs. corrugator supercilii and flexor hallucis brevis. Sci Rep. 2025 Jul 14;15(1):25426. doi: 10.1038/s41598-025-11259-5.
PubMed 40659829
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Neuromuscular Transmission in the Arm and Hand Muscles With Alternative Muscles Such as the Lower Leg Muscles and the Corrugator Supercilii During General Anesthesia
- ClinicalTrials.gov ID
- NCT04845386
- Acronym / sponsor ID
- Mivacron 2021
- Conditions
- Neuromuscular Blockade
- Keywords
- TOF Cuff, TOF Scan, Neuromuscular transmission, corrugator supercilii, Mivacurium, adductor pollicis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of Warmia and Mazury in OlsztynUniversity, hospital or other
- Collaborators
- Regional Specialized Hospital in Olsztyn
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 15 Apr 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 investigators want to compare new muscle relaxation monitoring, TOF-Cuff and TOF-Scan, during general anesthesia. Standard monitoring is using thumb, however it can't be use on every patient. Alternative can be eyebrow muscle or foot muscle.
There is only few old study that compares this muscle and used mivacurium. The study aims to compare TOF-Cuff and TOF-Scan with different sensor and use mivacurium.
Detailed description
In our research in addition to the standard intraoperative monitoring, which includes the assessment of ECG and saturation, the investigators would like to estimate muscle relaxation by using two different methods: a TOF-Cuff which additionally allows to measure inoperative blood pressure and TOF-Scan with different sensor. Our aim is to compare two different methods of muscle relaxation monitoring in patients who will administer muscle relaxant - mivacurium. After receiving painkillers and hypnotics, when the patient is falling asleep, the standard dose of mivacurium 0.2 mg / kg body weight will be administered. Then, painless simultaneous stimulation with TOF-Cuff and TOF-Scan devices will begin. Until intubation, measurements will be made in every 30 seconds and then every 5 minutes until extubation. Extubation will take place according to the guidelines when the TOF-Cuff measurement on the arm is greater than 0.9 - this is the value at which the patient is considered ready to start breathing on his own. The following will be documented: the initiation of drug administration, intubation, possible repeated doses of mivacurium 2 mg, antagonization, extubation, possible side effects (e.g., transient cardiac disturbances, reddening of the skin, lowering blood pressure, bronchospasm, erythema, urticaria) and technical problems.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TOF Cuff on arm and TOF Scan on corrugator supercilii | – | Device: TOF Cuff on arm, Device: TOF Scan on corrugator superciliiPatients undergoing surgery with intubation and receiving a intubation dose of mivacurium (0.2 mg/kg) and repeated dose of mivacurium (2mg) depending of needing under, routine gas anesthesia will have monitoring of neuromuscular block with two monitors simultaneously. |
| TOF Cuff on lower leg and TOF Scan on adductor pollicis | – | Device: TOF Cuff on lower leg, Device: TOF Scan on adductor pollicisPatients undergoing surgery with intubation and receiving a intubation dose of mivacurium (0.2 mg/kg) and repeated dose of mivacurium (2mg) depending of needing under, routine gas anesthesia will have monitoring of neuromuscular block with two monitors simultaneously. |
| TOF Scan on adductor pollicis and TOF Scan on toe | – | Device: TOF Scan on toe, Device: TOF Scan on adductor pollicisPatients undergoing surgery with intubation and receiving a intubation dose of mivacurium (0.2 mg/kg) and repeated dose of mivacurium (2mg) depending of needing under, routine gas anesthesia will have monitoring of neuromuscular block with two monitors simultaneously. |
| TOF Scan on adductor pollicis and TOF Cuff on arm | – | Device: TOF Cuff on arm, Device: TOF Scan on adductor pollicisPatients undergoing surgery with intubation and receiving a intubation dose of mivacurium (0.2 mg/kg) and repeated dose of mivacurium (2mg) depending of needing under, routine gas anesthesia will have monitoring of neuromuscular block with two monitors simultaneously. |
| TOF Scan on adductor pollicis and TOF Scan on corrugator supercilii | – | Device: TOF Scan on adductor pollicis, Device: TOF Scan on corrugator superciliiPatients undergoing surgery with intubation and receiving a intubation dose of mivacurium (0.2 mg/kg) and repeated dose of mivacurium (2mg) depending of needing under, routine gas anesthesia will have monitoring of neuromuscular block with two monitors simultaneously. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In the study will take patients qualified to the elective surgery
Key inclusion criteria (6 listed)
- Age 18-75
- ASA classification I,II,III
- Elective surgery
- BMI(body mass index) 17-35
- Surgery in the supine position
Key exclusion criteria (9 listed)
- Pregnancy and breastfeeding
- Urgent indications for surgery
- ASA classification >III
- Neuromuscular diseases
- Polyneuropathy
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 |
|---|---|---|
| TOF Cuff on armThe TOF Cuff will be installed on one arm in opposite of TOF Scan. After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block. | Device | TOF Cuff on arm and TOF Scan on corrugator supercilii, TOF Scan on adductor pollicis and TOF Cuff on arm |
| TOF Cuff on lower legThe TOF Cuff will be installed on one lower leg. After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block. | Device | TOF Cuff on lower leg and TOF Scan on adductor pollicis |
| TOF Scan on toeThe TOF Scan will be installed on hallux . After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block. | Device | TOF Scan on adductor pollicis and TOF Scan on toe |
| TOF Scan on adductor pollicisThe TOF Scan will be installed on Thumb. After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block. | Device | TOF Cuff on lower leg and TOF Scan on adductor pollicis, TOF Scan on adductor pollicis and TOF Cuff on arm, TOF Scan on adductor pollicis and TOF Scan on corrugator supercilii, TOF Scan on adductor pollicis and TOF Scan on toe |
| TOF Scan on corrugator superciliiThe TOF Scan will be installed on corrugator supercilii. After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block. | Device | TOF Cuff on arm and TOF Scan on corrugator supercilii, TOF Scan on adductor pollicis and TOF Scan on corrugator supercilii |
Primary outcome
Onset time
Time frame: 1 to 10 minutes
Time in seconds from start of injection of mivacurium until emergence of TOF ratio of 0%. TOF = Train of Four
Total recovery time of neuromuscular block
Time frame: 30 to 500 minutes
The total recovery time, i.e. total duration of the neuromuscular block is defined as the time in minutes from start of injection of mivacurium until a normalized TOF ratio of 90%
1 secondary outcome
Time to repeated dose
Time frame: 5 to 200 minutes
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 31 May 2022.
- Derived from this study: PubMed 40659829Radkowski P, Rusc J, Keska M, Onichimowski D. Comparison of TOF scan neuromuscular monitoring on adductor pollicis vs. corrugator supercilii and flexor hallucis brevis. Sci Rep. 2025 Jul 14;15(1):25426. doi: 10.1038/s41598-025-11259-5.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Neuromuscular Blockade, run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.
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 6 inclusion and 9 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 31 May 2022. 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 Poland. 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?
Onset time (time frame: 1 to 10 minutes). The study lists 2 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 NCT04845386, 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 31 May 2022.