Patients Undergoing General AnesthesiaMMG vs EMG NGNCT07750405
A Comparative Study of the Next-Generation TetraGraph® and Mechanomyography Neuromuscular Monitors in Clinical Settings
An observational study of Patients Undergoing General Anesthesia, run by University of Debrecen at 1 site in Hungary.
Trial summary
Background: Neuromuscular monitoring plays a critical role in reducing postoperative residual neuromuscular blockade (PRNB), a significant risk factor for respiratory complications. Despite the availability of various monitoring techniques, the validation of newer devices remains an ongoing challenge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing General Anesthesia
- What is being tested?
- Mechanomiograph (MMG) and Electromiograph (EMG)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteHungary
- Study dates
- 24 Sep 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: patients undergoing general surgery
Who may be able to join
- Age 18 years or older.
- ASA (American Society of Anesthesiology) physical status I-III.
- Written informed consent.
- The use of a medium-acting muscle relaxant is required for the surgery.
Who cannot join
- History of neuromuscular disease (e.g., stroke with hemiplegic symptoms, myasthenia gravis, severe polyneuropathy).
- Use of medications affecting neuromuscular transmission.
- Open wound or rash in the area corresponding to the electrode placement.
- Anticipated difficult intubation.
- Pregnancy, breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site
University of Debrecen, Department of Anesthesiology and Intensive Care
Debrecen, Hajdú-Bihar, 4032
Béla Fülesdi, MD, +36303838557, fulesdi@med.unideb.hu
László Asztalos, MD, +36307371315, asztalos.laszlo@med.unideb.hu
About this study
Official title: Comparative Clinical Evaluation of the Next-Generation TetraGraph® and Mechanomyography for Quantitative Neuromuscular Monitoring
Background: Neuromuscular monitoring plays a critical role in reducing postoperative residual neuromuscular blockade (PRNB), a significant risk factor for respiratory complications. Despite the availability of various monitoring techniques, the validation of newer devices remains an ongoing challenge. This study compares the performance of the electromyography (EMG)-based New Generation Tetragraph neuromuscular monitor with the gold standard mechanomyography (MMG) device, focusing on their accuracy and reliability in clinical settings.
Methods: Twenty cases were conducted during general surgeries requiring neuromuscular relaxation. Ulnar nerve was stimulated via the Tetragraph which detected the compound muscle action potential (CMAP) of adductor pollicis muscle. Simultaneously on the same arm the isometric force of the same stimulated muscle was registrated by the MMG and displayed in the Labchart 8 program. Bland-Altman analysis was used to describe the agreement between devices during distinct phases of neuromuscular blockade. The primary endpoint of the study was the comparison of TOF (Train Of Four) values of MMG and EMG during induction. In recovery, two groups were made from TOFRs: below and above the recommended muscle recovery to exclude PRNB (TOFR≥90%) (Fuchs-Buder 2023). Additionally, in deeper neuromuscular blockade Train-of-Four Count (TOFC), and Post-Tetanic Count (PTC) values were also analysed.
- Conditions
- Patients Undergoing General Anesthesia
- Being tested
- Mechanomiograph (MMG), Electromiograph (EMG)
- Keywords
- neuromuscular monitoring, MMG, EMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanomiograph (MMG)Device
The "gold standard" of quantitative monitoring is mechanomyography (MMG), which measures the force of contraction of the adductor pollicis muscle following ulnar nerve stimulation. MMG responses are accurate and reproducible. However, the complex and bulky devices are only suitable for research use, are not suitable for clinical use and are not commercially available.
Electromiograph (EMG)Device
Another type of monitor is the electromyograph, which can be seen as an alternative to mechanomyography because of its accuracy. This technique measures muscle activity as a summation of the action potentials of muscle fibres. This activity is proportional to the strength of the muscle contraction. The most commonly innervated nerve is also the ulnar nerve, which innervates the abductor digiti minimi and the first dorsalis interosseus muscles. During the measurements, electrical signals from these muscles are detected. EMG has several advantages over other monitoring techniques. It does not require immobilisation of the hand, thumb immobility is not a problem, no preload is required, and hypothermia does not affect the hand as much as other neuromuscular monitors. The TetraGraph (Senzime AB, Sweden) is a portable EMG-based neuromuscular minitor for which the manufacturers received marketing approval from the U.S. Food and Drug Administration (FDA) in 2019.
| Study group | Role | What they receive |
|---|---|---|
| 20 surgical patients | undergoing surgical procedures and receiving muscle relaxation Receives: Device: Mechanomiograph (MMG); Device: Electromiograph (EMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
concordance between the two devices.
The primary endpoint of the study is to compare TOF (Train of Four) values measured using mechanomyography and electromyography, and to assess the measurement concordance between the two devices.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start24 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing General AnesthesiaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Debrecen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pongrácz Adrienn, University of Debrecen
- Investigators
- László Asztalos, MD, Study director, University of Debrecen, Department of Anesthesiology and Intensive CareLászló Asztalos, MD, Principal investigator, University of Debrecen, Department of Anesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750405
- Sponsor's protocol ID
- AITT 2026/2
- Other IDs
- BM/13493-3/2026
- Acronym
- MMG vs EMG NG
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.
PubMed 17635389Ebert TJ, Vogt JA, Kaur R, Iqbal Z, Peters DJ, Cummings CE, Stekiel TA. Train-of-four ratio, counts and post tetanic counts with the Tetragraph electromyograph in comparison to mechanomyography. J Clin Monit Comput. 2025 Feb;39(1):149-156. doi: 10.1007/s10877-024-01225-3. Epub 2024 Oct 18.
PubMed 39424740Sato H, Iwasaki H, Doshu-Kajiura A, Katagiri S, Takagi S, Luthe SK, Suzuki T. Comparison of two electromyography-based neuromuscular monitors, AF-201P and TetraGraph, in rocuronium-induced neuromuscular block: A prospective comparative study. Anaesth Crit Care Pain Med. 2022 Dec;41(6):101145. doi: 10.1016/j.accpm.2022.101145. Epub 2022 Aug 31.
PubMed 36057386Nemes R, Lengyel S, Nagy G, Hampton DR, Gray M, Renew JR, Tassonyi E, Fulesdi B, Brull SJ. Ipsilateral and Simultaneous Comparison of Responses from Acceleromyography- and Electromyography-based Neuromuscular Monitors. Anesthesiology. 2021 Oct 1;135(4):597-611. doi: 10.1097/ALN.0000000000003896.
PubMed 34329371Kopman AF, Justo MD, Mallhi MU, Abara CE, Neuman GG. The influence of changes in hand temperature on the indirectly evoked electromyogram of the first dorsal interosseous muscle. Can J Anaesth. 1995 Dec;42(12):1090-5. doi: 10.1007/BF03015094.
PubMed 8595683Engbaek J, Skovgaard LT, Friis B, Kann T, Viby-Mogensen J. Monitoring of the neuromuscular transmission by electromyography (I). Stability and temperature dependence of evoked EMG response compared to mechanical twitch recordings in the cat. Acta Anaesthesiol Scand. 1992 Aug;36(6):495-504. doi: 10.1111/j.1399-6576.1992.tb03506.x.
PubMed 1325093Naguib M, Brull SJ, Johnson KB. Conceptual and technical insights into the basis of neuromuscular monitoring. Anaesthesia. 2017 Jan;72 Suppl 1:16-37. doi: 10.1111/anae.13738.
PubMed 28044330Naguib M, Kopman AF, Ensor JE. Neuromuscular monitoring and postoperative residual curarisation: a meta-analysis. Br J Anaesth. 2007 Mar;98(3):302-16. doi: 10.1093/bja/ael386.
PubMed 17307778Todd MM, Hindman BJ, King BJ. The implementation of quantitative electromyographic neuromuscular monitoring in an academic anesthesia department. Anesth Analg. 2014 Aug;119(2):323-331. doi: 10.1213/ANE.0000000000000261.
PubMed 24878683Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
PubMed 18635478Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. doi: 10.1111/j.1399-6576.1997.tb04851.x.
PubMed 9366929Eriksson LI. Reduced hypoxic chemosensitivity in partially paralysed man. A new property of muscle relaxants? Acta Anaesthesiol Scand. 1996 May;40(5):520-3. doi: 10.1111/j.1399-6576.1996.tb04482.x.
PubMed 8792879Sundman E, Witt H, Olsson R, Ekberg O, Kuylenstierna R, Eriksson LI. The incidence and mechanisms of pharyngeal and upper esophageal dysfunction in partially paralyzed humans: pharyngeal videoradiography and simultaneous manometry after atracurium. Anesthesiology. 2000 Apr;92(4):977-84. doi: 10.1097/00000542-200004000-00014.
PubMed 10754616Eriksson LI, Sato M, Severinghaus JW. Effect of a vecuronium-induced partial neuromuscular block on hypoxic ventilatory response. Anesthesiology. 1993 Apr;78(4):693-9. doi: 10.1097/00000542-199304000-00012.
PubMed 8096684Arbous MS, Meursing AE, van Kleef JW, de Lange JJ, Spoormans HH, Touw P, Werner FM, Grobbee DE. Impact of anesthesia management characteristics on severe morbidity and mortality. Anesthesiology. 2005 Feb;102(2):257-68; quiz 491-2. doi: 10.1097/00000542-200502000-00005.
PubMed 15681938
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Evaluation of the Next-Generation TetraGraph® and Mechanomyography for Quantitative Neuromuscular Monitoring
- ClinicalTrials.gov ID
- NCT07750405
- Acronym / sponsor ID
- MMG vs EMG NG / AITT 2026/2
- Conditions
- Patients Undergoing General Anesthesia
- Keywords
- neuromuscular monitoring, MMG, EMG
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of DebrecenUniversity, hospital or other
- Study start
- 24 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Aug 2026 (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.
Background: Neuromuscular monitoring plays a critical role in reducing postoperative residual neuromuscular blockade (PRNB), a significant risk factor for respiratory complications. Despite the availability of various monitoring techniques, the validation of newer devices remains an ongoing challenge. This study compares the performance of the electromyography (EMG)-based New Generation Tetragraph neuromuscular monitor with the gold standard mechanomyography (MMG) device, focusing on their accuracy and reliability in clinical settings.
Methods: Twenty cases were conducted during general surgeries requiring neuromuscular relaxation. Ulnar nerve was stimulated via the Tetragraph which detected the compound muscle action potential (CMAP) of adductor pollicis muscle. Simultaneously on the same arm the isometric force of the same stimulated muscle was registrated by the MMG and displayed in the Labchart 8 program. Bland-Altman analysis was used to describe the agreement between devices during distinct phases of neuromuscular blockade. The primary endpoint of the study was the comparison of TOF (Train Of Four) values of MMG and EMG during induction. In recovery, two groups were made from TOFRs: below and above the recommended muscle recovery to exclude PRNB (TOFR≥90%) (Fuchs-Buder 2023). Additionally, in deeper neuromuscular blockade Train-of-Four Count (TOFC), and Post-Tetanic Count (PTC) values were also analysed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 surgical patients | – | Device: Mechanomiograph (MMG), Device: Electromiograph (EMG)undergoing surgical procedures and receiving muscle relaxation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing general surgery
Key inclusion criteria (4 listed)
- Age 18 years or older.
- ASA (American Society of Anesthesiology) physical status I-III.
- Written informed consent.
- The use of a medium-acting muscle relaxant is required for the surgery.
Key exclusion criteria (5 listed)
- History of neuromuscular disease (e.g., stroke with hemiplegic symptoms, myasthenia gravis, severe polyneuropathy).
- Use of medications affecting neuromuscular transmission.
- Open wound or rash in the area corresponding to the electrode placement.
- Anticipated difficult intubation.
- Pregnancy, breastfeeding.
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 |
|---|---|---|
| Mechanomiograph (MMG)The "gold standard" of quantitative monitoring is mechanomyography (MMG), which measures the force of contraction of the adductor pollicis muscle following ulnar nerve stimulation. MMG responses are accurate and reproducible. However, the complex and bulky devices are only suitable for research use, are not suitable for clinical use and are not commercially available. | Device | 20 surgical patients |
| Electromiograph (EMG)Another type of monitor is the electromyograph, which can be seen as an alternative to mechanomyography because of its accuracy. This technique measures muscle activity as a summation of the action potentials of muscle fibres. This activity is proportional to the strength of the muscle contraction. The most commonly innervated nerve is also the ulnar nerve, which innervates the abductor digiti minimi and the first dorsalis interosseus muscles. During the measurements, electrical signals from these muscles are detected. EMG has several advantages over other monitoring techniques. It does not require immobilisation of the hand, thumb immobility is not a problem, no preload is required, and hypothermia does not affect the hand as much as other neuromuscular monitors. The TetraGraph (Senzime AB, Sweden) is a portable EMG-based neuromuscular minitor for which the manufacturers received marketing approval from the U.S. Food and Drug Administration (FDA) in 2019. | Device | 20 surgical patients |
Primary outcome
concordance between the two devices.
Time frame: intraoperative
The primary endpoint of the study is to compare TOF (Train of Four) values measured using mechanomyography and electromyography, and to assess the measurement concordance between the two devices.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 17635389Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.
- Background: PubMed 39424740Ebert TJ, Vogt JA, Kaur R, Iqbal Z, Peters DJ, Cummings CE, Stekiel TA. Train-of-four ratio, counts and post tetanic counts with the Tetragraph electromyograph in comparison to mechanomyography. J Clin Monit Comput. 2025 Feb;39(1):149-156. doi: 10.1007/s10877-024-01225-3. Epub 2024 Oct 18.
- Background: PubMed 36057386Sato H, Iwasaki H, Doshu-Kajiura A, Katagiri S, Takagi S, Luthe SK, Suzuki T. Comparison of two electromyography-based neuromuscular monitors, AF-201P and TetraGraph, in rocuronium-induced neuromuscular block: A prospective comparative study. Anaesth Crit Care Pain Med. 2022 Dec;41(6):101145. doi: 10.1016/j.accpm.2022.101145. Epub 2022 Aug 31.
- Background: PubMed 34329371Nemes R, Lengyel S, Nagy G, Hampton DR, Gray M, Renew JR, Tassonyi E, Fulesdi B, Brull SJ. Ipsilateral and Simultaneous Comparison of Responses from Acceleromyography- and Electromyography-based Neuromuscular Monitors. Anesthesiology. 2021 Oct 1;135(4):597-611. doi: 10.1097/ALN.0000000000003896.
- Background: PubMed 8595683Kopman AF, Justo MD, Mallhi MU, Abara CE, Neuman GG. The influence of changes in hand temperature on the indirectly evoked electromyogram of the first dorsal interosseous muscle. Can J Anaesth. 1995 Dec;42(12):1090-5. doi: 10.1007/BF03015094.
- Background: PubMed 1325093Engbaek J, Skovgaard LT, Friis B, Kann T, Viby-Mogensen J. Monitoring of the neuromuscular transmission by electromyography (I). Stability and temperature dependence of evoked EMG response compared to mechanical twitch recordings in the cat. Acta Anaesthesiol Scand. 1992 Aug;36(6):495-504. doi: 10.1111/j.1399-6576.1992.tb03506.x.
- Background: PubMed 28044330Naguib M, Brull SJ, Johnson KB. Conceptual and technical insights into the basis of neuromuscular monitoring. Anaesthesia. 2017 Jan;72 Suppl 1:16-37. doi: 10.1111/anae.13738.
- Background: PubMed 17307778Naguib M, Kopman AF, Ensor JE. Neuromuscular monitoring and postoperative residual curarisation: a meta-analysis. Br J Anaesth. 2007 Mar;98(3):302-16. doi: 10.1093/bja/ael386.
- Background: PubMed 24878683Todd MM, Hindman BJ, King BJ. The implementation of quantitative electromyographic neuromuscular monitoring in an academic anesthesia department. Anesth Analg. 2014 Aug;119(2):323-331. doi: 10.1213/ANE.0000000000000261.
- Background: PubMed 18635478Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
- Background: PubMed 9366929Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. doi: 10.1111/j.1399-6576.1997.tb04851.x.
- Background: PubMed 8792879Eriksson LI. Reduced hypoxic chemosensitivity in partially paralysed man. A new property of muscle relaxants? Acta Anaesthesiol Scand. 1996 May;40(5):520-3. doi: 10.1111/j.1399-6576.1996.tb04482.x.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
László Asztalos, MD study director
University of Debrecen, Department of Anesthesiology and Intensive Care
László Asztalos, MD principal investigator
University of Debrecen, Department of Anesthesiology and Intensive Care
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 Patients Undergoing General Anesthesia, run by University of Debrecen at 1 site in Hungary.
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 4 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: opening soon, as of the sponsor's last update on 29 Sep 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Béla Fülesdi, MD (+36303838557, fulesdi@med.unideb.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concordance between the two devices. (time frame: intraoperative). 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 NCT07750405, which also lists 15 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 29 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.