Neuromuscular BlockadeNCT04282213
Neuromuscular Monitoring:TOFCuff Versus EMG
An observational study of Neuromuscular Blockade, run by Servei Central d'Anestesiologia at 1 site in Spain.
Trial summary
Mechanomyography (MMG) is considered the gold-standard for neuromuscular blockade (NMB) monitoring. However, it is quite bulky and difficult to use on a routine basis. Therefore, alternative methods like Acceleromyography (AMG), Electromyography (EMG) and the TOF-CUFF method have been developed. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Blockade
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2020to 10 May 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients American Society of Anesthesiologist (ASA) I-II, between 18-65 years and scheduled for elective surgery under general anesthesia.
Who may be able to join
- ASA I-II
- Patients who give their written informed consent
- Elective surgery under general anesthesia that according to the anesthetic plan muscle relaxants will be administered
Who cannot join
- Patients who refuse to give their informed consent
- Patients who present any of the contraindications for the devices used in the study
- Patients who are participating or have participated in a clinical trial during the 4 weeks prior to inclusion
- Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or breast-feeding
- Patients with the following criteria: upper limb peripheral vascular pathologies, a difficult airway, myasthenia gravis and other neuromuscular diseases, use of medication that may alter NMT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the TOFCuff Monitor Versus Electromyography in Neuromuscular Monitoring
Mechanomyography (MMG) is considered the gold-standard for neuromuscular blockade (NMB) monitoring. However, it is quite bulky and difficult to use on a routine basis. Therefore, alternative methods like Acceleromyography (AMG), Electromyography (EMG) and the TOF-CUFF method have been developed. The aim of this study was to compare the TOF-Cuff monitor and Electromyography (EMG-NMT module with the CARESCAPE B450 monitor) data following rocuronium-induced neuromuscular blockade and its reversal.
Read the detailed description
Neuromuscular relaxation of the patient during surgery is necessary for multiple reasons, such as facilitating intubation or improving the effectiveness of some surgical procedures. Premature extubation of the patient without having achieved a complete recovery of the NMB can have deleterious consequences, increasing postoperative complications, especially those related to the respiratory system. Given this, current guidelines of good clinical practice recommend the monitoring of pharmacologically induced NMB during general anesthesia. In addition, monitoring allows confirmation of optimum relaxation before intubation, and allows for control over re-dose administration and recovery of NMB upon awakening from general anesthesia.
There are different methods of quantitative monitoring of NMB. The TOF-CUFF monitor uses a method based on a traditional pressure cuff that incorporates stimulation electrodes. The placement of the cuff which aligns the stimulation electrodes on the path of the brachial plexus at the humeral level allows to evaluate the muscular response evoked from the changes in the cuff pressure, generated by the muscular contraction after the electrical stimulus. Its main advantage is that monitoring of the NMB is included within the pressure cuff itself, which is always used in any anesthetic act. Then, when the pressure cuff is placed, monitoring of the NMB is easily established. This specific design facilitates the task of anesthesiologists because they do not have to perform any additional preparation for the monitoring of NMB.
The TOF-CUFF monitor has been validated regarding the mechanomyography, which is considered the gold-standard for the monitoring of NMB. The main objective of the study is to compare the values of NMB measured with the TOF-CUFF monitor with NMB values measured with the CARESCAPE B450 monitor during the pharmacologically induced NMB and evaluate the degree of equivalence in different situations. Secondary objective is to verify that the design for joint monitoring of the NMB and NIBP in the TOF-CUFF monitor does not affect the independent measure of the two variables.
Prospective, single-center, open and controlled observational clinical study. The study is aimed to be conducted with 40 patients aged between 18 and 65 years.
- Conditions
- Neuromuscular Blockade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control samples | For each case, neuromuscular measurements gathered with GE CARESCAPE B450 monitor (E-NMT module). | |
| Case samples | For each case, neuromuscular measurements gathered with TOFCuff monitor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
TOFR (Train Of Four Ratio)
For this measurement, patient is stimulated with four twitches at a known stimulation current. Each twitch is performed every 500ms. The neuromuscular response for each twitch is gathered. Train Of Four ratio consists of the weighting of the fourth stimulus against the first stimulus.
It can be calculated also as a percentage.
Measured: Baseline
Counts
When performing the Train Of Four (TOF) measurement, count of the twitches that are higher than 0.
Measured: Baseline
PTC
Once patient is in a deep neuromuscular blockade, all twitches from Train Of Four (TOF) measurement are 0. In order to evaluate the neuromuscular response, Post Tetanic Count (PTC) measurement is performed.
PTC is splitted in two steps. First, during 5 seconds a tetanic stimulation is performed at 50Hz. If no response is elicited, after a pause of 3 seconds 15 single-twitch stimualtion at 1Hz are performed. PTC value is the count of the single-twitches that are higher than 0.
Measured: Baseline
T1
For Train Of Four (TOF) measurement, amplitude of the first neuromuscular stimulation response. Units depend on the measurement techniques.
Measured: Baseline
T2
For Train Of Four (TOF) measurement, amplitude of the second neuromuscular stimulation response. Units depend on the measurement techniques.
Measured: Baseline
T3
For Train Of Four (TOF) measurement, amplitude of the third neuromuscular stimulation response. Units depend on the measurement techniques.
Measured: Baseline
T4
For Train Of Four (TOF) measurement, amplitude of the fourth neuromuscular stimulation response. Units depend on the measurement techniques.
Measured: Baseline
PID
Diastolic pressure in mmHg
Measured: Baseline
PIS
Systolic pressure in mmHg
Measured: Baseline
PIM
Mean pressure in mmHg
Measured: Baseline
Secondary outcomes (1)
Temperature
Patient temperature on the palm hand
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start15 Jan 2020
- Primary completion10 May 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servei Central d'Anestesiologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorena Silva Gil, Servei Central d'Anestesiologia
- Investigators
- Lorena Silva Gil, MD, Principal investigator, Servei d'Anestesiologia Centro Médico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282213
- Sponsor's protocol ID
- NMT2020
- Status last verified
- Sep 2021
- First submitted
- 19 Feb 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naguib M, Kopman AF, Lien CA, Hunter JM, Lopez A, Brull SJ. A survey of current management of neuromuscular block in the United States and Europe. Anesth Analg. 2010 Jul;111(1):110-9. doi: 10.1213/ANE.0b013e3181c07428. Epub 2009 Nov 12.
PubMed 19910616Veiga Ruiz G, Garcia Cayuela J, Orozco Montes J, Parreno Caparros M, Garcia Rojo B, Aguayo Albasini JL. Monitoring intraoperative neuromuscular blockade and blood pressure with one device (TOF-Cuff): A comparative study with mechanomyography and invasive blood pressure. Rev Esp Anestesiol Reanim. 2017 Dec;64(10):560-567. doi: 10.1016/j.redar.2017.03.013. Epub 2017 Jun 27. English, Spanish.
PubMed 28662770Rodiera J, Serradell A, Alvarez-Gomez JA, Aliaga L. The cuff method: a pilot study of a new method of monitoring neuromuscular function. Acta Anaesthesiol Scand. 2005 Nov;49(10):1552-8. doi: 10.1111/j.1399-6576.2005.00777.x.
PubMed 16223405Checketts MR, Jenkins B, Pandit JJ. Implications of the 2015 AAGBI recommendations for standards of monitoring during anaesthesia and recovery. Anaesthesia. 2017 Jan;72 Suppl 1:3-6. doi: 10.1111/anae.13736. No abstract available.
PubMed 28044335Dahaba AA, von Klobucar F, Rehak PH, List WF. The neuromuscular transmission module versus the relaxometer mechanomyograph for neuromuscular block monitoring. Anesth Analg. 2002 Mar;94(3):591-6; table of contents. doi: 10.1097/00000539-200203000-00021.
PubMed 11867381
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the TOFCuff Monitor Versus Electromyography in Neuromuscular Monitoring
- ClinicalTrials.gov ID
- NCT04282213
- Acronym / sponsor ID
- NMT2020
- Conditions
- Neuromuscular Blockade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Servei Central d'AnestesiologiaUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 24 Feb 2020 (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.
Mechanomyography (MMG) is considered the gold-standard for neuromuscular blockade (NMB) monitoring. However, it is quite bulky and difficult to use on a routine basis. Therefore, alternative methods like Acceleromyography (AMG), Electromyography (EMG) and the TOF-CUFF method have been developed. The aim of this study was to compare the TOF-Cuff monitor and Electromyography (EMG-NMT module with the CARESCAPE B450 monitor) data following rocuronium-induced neuromuscular blockade and its reversal.
Detailed description
Neuromuscular relaxation of the patient during surgery is necessary for multiple reasons, such as facilitating intubation or improving the effectiveness of some surgical procedures. Premature extubation of the patient without having achieved a complete recovery of the NMB can have deleterious consequences, increasing postoperative complications, especially those related to the respiratory system. Given this, current guidelines of good clinical practice recommend the monitoring of pharmacologically induced NMB during general anesthesia. In addition, monitoring allows confirmation of optimum relaxation before intubation, and allows for control over re-dose administration and recovery of NMB upon awakening from general anesthesia.
There are different methods of quantitative monitoring of NMB. The TOF-CUFF monitor uses a method based on a traditional pressure cuff that incorporates stimulation electrodes. The placement of the cuff which aligns the stimulation electrodes on the path of the brachial plexus at the humeral level allows to evaluate the muscular response evoked from the changes in the cuff pressure, generated by the muscular contraction after the electrical stimulus. Its main advantage is that monitoring of the NMB is included within the pressure cuff itself, which is always used in any anesthetic act. Then, when the pressure cuff is placed, monitoring of the NMB is easily established. This specific design facilitates the task of anesthesiologists because they do not have to perform any additional preparation for the monitoring of NMB.
The TOF-CUFF monitor has been validated regarding the mechanomyography, which is considered the gold-standard for the monitoring of NMB. The main objective of the study is to compare the values of NMB measured with the TOF-CUFF monitor with NMB values measured with the CARESCAPE B450 monitor during the pharmacologically induced NMB and evaluate the degree of equivalence in different situations. Secondary objective is to verify that the design for joint monitoring of the NMB and NIBP in the TOF-CUFF monitor does not affect the independent measure of the two variables.
Prospective, single-center, open and controlled observational clinical study. The study is aimed to be conducted with 40 patients aged between 18 and 65 years.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control samples | – | –For each case, neuromuscular measurements gathered with GE CARESCAPE B450 monitor (E-NMT module). |
| Case samples | – | –For each case, neuromuscular measurements gathered with TOFCuff monitor. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients American Society of Anesthesiologist (ASA) I-II, between 18-65 years and scheduled for elective surgery under general anesthesia.
Key inclusion criteria (3 listed)
- ASA I-II
- Patients who give their written informed consent
- Elective surgery under general anesthesia that according to the anesthetic plan muscle relaxants will be administered
Key exclusion criteria (5 listed)
- Patients who refuse to give their informed consent
- Patients who present any of the contraindications for the devices used in the study
- Patients who are participating or have participated in a clinical trial during the 4 weeks prior to inclusion
- Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or breast-feeding
- Patients with the following criteria: upper limb peripheral vascular pathologies, a difficult airway, myasthenia gravis and other neuromuscular diseases, use of medication that may alter NMT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TOFR (Train Of Four Ratio)
Time frame: Baseline
For this measurement, patient is stimulated with four twitches at a known stimulation current. Each twitch is performed every 500ms. The neuromuscular response for each twitch is gathered. Train Of Four ratio consists of the weighting of the fourth stimulus against the first stimulus. It can be calculated also as a percentage.
Counts
Time frame: Baseline
When performing the Train Of Four (TOF) measurement, count of the twitches that are higher than 0.
PTC
Time frame: Baseline
Once patient is in a deep neuromuscular blockade, all twitches from Train Of Four (TOF) measurement are 0. In order to evaluate the neuromuscular response, Post Tetanic Count (PTC) measurement is performed. PTC is splitted in two steps. First, during 5 seconds a tetanic stimulation is performed at 50Hz. If no response is elicited, after a pause of 3 seconds 15 single-twitch stimualtion at 1Hz are performed. PTC value is the count of the single-twitches that are higher than 0.
T1
Time frame: Baseline
For Train Of Four (TOF) measurement, amplitude of the first neuromuscular stimulation response. Units depend on the measurement techniques.
T2
Time frame: Baseline
For Train Of Four (TOF) measurement, amplitude of the second neuromuscular stimulation response. Units depend on the measurement techniques.
T3
Time frame: Baseline
For Train Of Four (TOF) measurement, amplitude of the third neuromuscular stimulation response. Units depend on the measurement techniques.
T4
Time frame: Baseline
For Train Of Four (TOF) measurement, amplitude of the fourth neuromuscular stimulation response. Units depend on the measurement techniques.
PID
Time frame: Baseline
Diastolic pressure in mmHg
PIS
Time frame: Baseline
Systolic pressure in mmHg
PIM
Time frame: Baseline
Mean pressure in mmHg
1 secondary outcome
Temperature
Time frame: Baseline
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 22 Sep 2021.
- Background: PubMed 19910616Naguib M, Kopman AF, Lien CA, Hunter JM, Lopez A, Brull SJ. A survey of current management of neuromuscular block in the United States and Europe. Anesth Analg. 2010 Jul;111(1):110-9. doi: 10.1213/ANE.0b013e3181c07428. Epub 2009 Nov 12.
- Background: PubMed 28662770Veiga Ruiz G, Garcia Cayuela J, Orozco Montes J, Parreno Caparros M, Garcia Rojo B, Aguayo Albasini JL. Monitoring intraoperative neuromuscular blockade and blood pressure with one device (TOF-Cuff): A comparative study with mechanomyography and invasive blood pressure. Rev Esp Anestesiol Reanim. 2017 Dec;64(10):560-567. doi: 10.1016/j.redar.2017.03.013. Epub 2017 Jun 27. English, Spanish.
- Background: PubMed 16223405Rodiera J, Serradell A, Alvarez-Gomez JA, Aliaga L. The cuff method: a pilot study of a new method of monitoring neuromuscular function. Acta Anaesthesiol Scand. 2005 Nov;49(10):1552-8. doi: 10.1111/j.1399-6576.2005.00777.x.
- Background: PubMed 28044335Checketts MR, Jenkins B, Pandit JJ. Implications of the 2015 AAGBI recommendations for standards of monitoring during anaesthesia and recovery. Anaesthesia. 2017 Jan;72 Suppl 1:3-6. doi: 10.1111/anae.13736. No abstract available.
- Background: PubMed 11867381Dahaba AA, von Klobucar F, Rehak PH, List WF. The neuromuscular transmission module versus the relaxometer mechanomyograph for neuromuscular block monitoring. Anesth Analg. 2002 Mar;94(3):591-6; table of contents. doi: 10.1097/00000539-200203000-00021.
- 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.
Lorena Silva Gil, MD principal investigator
Servei d'Anestesiologia Centro Médico Teknon
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 Servei Central d'Anestesiologia at 1 site in Spain.
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 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 22 Sep 2021. 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 Spain. 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?
TOFR (Train Of Four Ratio) (time frame: Baseline). The study lists 10 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 NCT04282213, which also lists 5 linked publications.
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 22 Sep 2021.