Comparison of Mechanomyographic 100 Versus 200 Hz 5 Second Tetanic Fade Ratios During Neuromuscular Block Recovery

NCT05474638 | Completed

• 1 other identifier: TFR 100 vs 200 Hz
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Two recent pilot studies suggested the potential interest of 100 and 200 Hz tetanic stimulations to detect with mechanomyography (MMG) very low levels of residual neuromuscular blockade (NMB). The Tetanic Fade Ratio (TFR, residual force after 5 seconds / maximal force) measured quantitatively by MMG during tetanic stimulation at 100 or 200 Hz could provide today a more consistent response than the train-of-four (TOF) ratio provided by acceleromyography (AMG) to this search for detection of low levels of residual NMB. This study was designed to evaluate for the first time in anesthetized patients the evolution of NMB spontaneous recovery with 5-second 100 and 200 Hz tetanic stimulations compared to TOF, and to test the hypothesis that a 200 Hz TFR would better and longer detect low levels of residual paralysis than AMG TOF ratio and 100 Hz TFR.

Conditions

Neuromuscular Blockade

Keywords

Residual neuromuscular block; Mechanomyography; Tetanic nerve stimulation

Outcome Measures

Primary Outcomes (1)

• 100 vs 200 Hz Tetanic Fade Ratio comparison

  To compare 100 and 200 Hz TFR at different literature based spontaneous recovery levels recorded by acceleromyography on the other arm: TOF count 1, TOF ratio 0.5 and TOF ratio 0.9 / normalized 0.9 / 0.95 / 1.0.

  During surgery while the neuromuscular block spontaneously recovers from AMG TOF count 1 until TOF ratio 1.0

Secondary Outcomes (1)

• Quantification of any remaining MMG fade with 200 Hz stimulation after AMG TOF ratio 0.9 recovery

  During surgery while the neuromuscular block spontaneously recovers from AMG TOF ratio 0.9 until MMG 200 Hz TFR > 0.9

Study Arms (1)

Controlateral and simultaneous comparison of neuromuscular transmission monitors

OTHER

Controlateral and simultaneous comparison of responses from acceleromyography- and mechanomyography-based neuromuscular transmission monitors in the same patients.

Device: Isometric Thumb Force (isometric mechanomyography) compared to TOF-Watch SX (acceleromyography)

Interventions

Isometric Thumb Force (isometric mechanomyography) compared to TOF-Watch SX (acceleromyography) DEVICE

Comparison of mechanomyographic measurements of thumb adduction's force induced by 100 versus 200 Hz 5 seconds tetanic ulnar nerve stimulation during neuromuscular block spontaneous recovery monitored by acceleromyography on the controlateral arm.

Controlateral and simultaneous comparison of neuromuscular transmission monitors

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II
• written informed consent
• general anesthesia for rhino(septo)plasty

You may not qualify if:

• pregnant or breastfeeding women
• patients with renal or hepatic insufficiency
• patients with neurological disorders
• patients with a suspected allergy to the drugs used in the protocol
• patients receiving medications that could interfere with neuromuscular transmission

Sponsors & Collaborators

• Centre Hospitalier Universitaire UCLouvain Namur: lead

Study Sites (1)

CHU Dinant-Godinne

Yvoir, 5530, Belgium

Location

Related Publications (16)

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  PMID: 5488360 BACKGROUND

• Gissen AJ, Katz RL. Twitch, tetanus and posttetanic potentiation as indices of nerve-muscle block in man. Anesthesiology. 1969 May;30(5):481-7. doi: 10.1097/00000542-196905000-00001. No abstract available.

  PMID: 4305092 BACKGROUND

• Waud BE, Waud DR. The relation between tetanic fade and receptor occlusion in the presence of competitive neuromuscular block. Anesthesiology. 1971 Nov;35(5):456-64. doi: 10.1097/00000542-197111000-00003. No abstract available.

  PMID: 4329144 BACKGROUND

• 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.

  PMID: 17635389 BACKGROUND

• Ali HH, Savarese JJ, Lebowitz PW, Ramsey FM. Twitch, tetanus and train-of-four as indices of recovery from nondepolarizing neuromuscular blockade. Anesthesiology. 1981 Apr;54(4):294-7. doi: 10.1097/00000542-198104000-00007.

  PMID: 6452074 BACKGROUND

• Stanec A, Heyduk J, Stanec G, Orkin LR. Tetanic fade and post-tetanic tension in the absence of neuromuscular blocking agents in anesthetized man. Anesth Analg. 1978 Jan-Feb;57(1):102-7. doi: 10.1213/00000539-197801000-00019.

  PMID: 204226 BACKGROUND

• Kopman AF, Epstein RH, Flashburg MH. Use of 100-Hertz tetanus as an index of recovery from pancuronium-induced non-depolarizing neuromuscular blockade. Anesth Analg. 1982 May;61(5):439-41.

  PMID: 7199868 BACKGROUND

• Eikermann M, Vogt FM, Herbstreit F, Vahid-Dastgerdi M, Zenge MO, Ochterbeck C, de Greiff A, Peters J. The predisposition to inspiratory upper airway collapse during partial neuromuscular blockade. Am J Respir Crit Care Med. 2007 Jan 1;175(1):9-15. doi: 10.1164/rccm.200512-1862OC. Epub 2006 Oct 5.

  PMID: 17023729 BACKGROUND

• Plaud B, Debaene B, Donati F, Marty J. Residual paralysis after emergence from anesthesia. Anesthesiology. 2010 Apr;112(4):1013-22. doi: 10.1097/ALN.0b013e3181cded07. No abstract available.

  PMID: 20234315 BACKGROUND

• Kirmeier E, Eriksson LI, Lewald H, Jonsson Fagerlund M, Hoeft A, Hollmann M, Meistelman C, Hunter JM, Ulm K, Blobner M; POPULAR Contributors. Post-anaesthesia pulmonary complications after use of muscle relaxants (POPULAR): a multicentre, prospective observational study. Lancet Respir Med. 2019 Feb;7(2):129-140. doi: 10.1016/S2213-2600(18)30294-7. Epub 2018 Sep 14.

  PMID: 30224322 BACKGROUND

• Blobner M, Hunter JM, Meistelman C, Hoeft A, Hollmann MW, Kirmeier E, Lewald H, Ulm K. Use of a train-of-four ratio of 0.95 versus 0.9 for tracheal extubation: an exploratory analysis of POPULAR data. Br J Anaesth. 2020 Jan;124(1):63-72. doi: 10.1016/j.bja.2019.08.023. Epub 2019 Oct 10.

  PMID: 31607388 BACKGROUND

• Capron F, Alla F, Hottier C, Meistelman C, Fuchs-Buder T. Can acceleromyography detect low levels of residual paralysis? A probability approach to detect a mechanomyographic train-of-four ratio of 0.9. Anesthesiology. 2004 May;100(5):1119-24. doi: 10.1097/00000542-200405000-00013.

  PMID: 15114208 BACKGROUND

• Suzuki T, Fukano N, Kitajima O, Saeki S, Ogawa S. Normalization of acceleromyographic train-of-four ratio by baseline value for detecting residual neuromuscular block. Br J Anaesth. 2006 Jan;96(1):44-7. doi: 10.1093/bja/aei273. Epub 2005 Nov 18.

  PMID: 16299046 BACKGROUND

• Dubois PE, Mitchell J, Regnier M, Passeraub PA, Moreillon F, d'Hollander AA. The interest of 100 versus 200 Hz tetanic stimulations to quantify low levels of residual neuromuscular blockade with mechanomyography: a pilot study. J Clin Monit Comput. 2022 Aug;36(4):1131-1137. doi: 10.1007/s10877-021-00745-6. Epub 2021 Jul 24.

  PMID: 34302578 BACKGROUND

• Debaene B, Frasca D, Moreillon F, D'Hollander AA. 100 Hz-5 s tetanic stimulation to illustrate the presence of "residual paralysis" co-existing with accelerometric 0.90 train-of-four ratio-A proof-of-concept study. Anaesth Crit Care Pain Med. 2021 Aug;40(4):100903. doi: 10.1016/j.accpm.2021.100903. Epub 2021 Jun 17.

  PMID: 34147687 BACKGROUND

• Dubois PE, Moreillon F, Bihin B, De Dorlodot C, Meyer S, Maseri A, Passeraub PA, d'Hollander AA. Spontaneous recovery from rocuronium measured by mechanomyography during 100- or 200-Hz tetanic stimulations compared to normalized train-of-four with acceleromyography. J Clin Monit Comput. 2025 Oct;39(5):1037-1045. doi: 10.1007/s10877-025-01282-2. Epub 2025 Apr 1.

  PMID: 40167977 DERIVED

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alain D'Hollander, Prof

  Fondation pour l'Anesthésie-Réanimation, Vaduz

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Philippe Dubois

Model Details: Controlateral and simultaneous comparison of two different neuromuscular transmission monitorings in a cohort of 20 anesthetised patients.

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 26, 2022
• Study Start: October 25, 2022
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Locations

BE (1)