Comparison of Adductor Pollicis and Abductor Digiti Minimi Muscles (Thumb Vs. Fifth Digit) As Sites for Neuromuscular Monitoring with Electromyography

NCT06691204 | Recruiting DMC

• 3 other identifiers: AITT 2023/7DE RKEB/IKEB 6656-2023BM/26645-1/2024
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate the performance of the TetraGraph on two muscle groups: the adductor pollicis and the abductor digiti minimi. Theese muscles are located on the arms. Key time points for assessment will include the onset of neuromuscular blockade and the recovery from rocuronium blockade using sugammadex.

Conditions

Postoperative Residual Curarization; Neuromuscular Blockade

Keywords

Electromyography

Outcome Measures

Primary Outcomes (1)

• The rate of recovery following sugammadex administration as recorded simultaneously from the hand (adductor pollicis) and fifth digit (abductor digiti minimi) muscles

  the time in seconds between the administration of the suggamedex and TOF 100%.

  depends on the depth of the neuromuscular block, a maximum of about 20 minutes

Secondary Outcomes (1)

• The incidence of postoperative residual weakness

  one hour after extubation

Eligibility Criteria

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

Study Population

Patients who receive a muscle relaxant (rocuronium bromide) for their operation to aid intubation and surgical exploration.

You may qualify if:

• Age \> or = 18 years old
• Patients willing to participate and provide an informed consent
• Patients undergoing elective surgical procedures that require use of NMBA agents (rocuronium) administered intraoperatively.

You may not qualify if:

• 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.
• Patients allergic to rocuronium or sugammadex.

Sponsors & Collaborators

• Tamas Vegh, MD: lead

Study Sites (2)

University of Debrecen, Department of Anesthesiology and Intensive Care

Debrecen, Hajdú-Bihar, 4032, Hungary

RECRUITING

University of Debrecen, Debrecen, Hajdú-Bihar 4008

Debrecen, Hungary

COMPLETED

Related Publications (11)

• Nemes R, Fulesdi B, Pongracz A, Asztalos L, Szabo-Maak Z, Lengyel S, Tassonyi E. Impact of reversal strategies on the incidence of postoperative residual paralysis after rocuronium relaxation without neuromuscular monitoring: A partially randomised placebo controlled trial. Eur J Anaesthesiol. 2017 Sep;34(9):609-616. doi: 10.1097/EJA.0000000000000585.

  PMID: 28030444 BACKGROUND

• Naguib M, Brull SJ, Kopman AF, Hunter JM, Fulesdi B, Arkes HR, Elstein A, Todd MM, Johnson KB. Consensus Statement on Perioperative Use of Neuromuscular Monitoring. Anesth Analg. 2018 Jul;127(1):71-80. doi: 10.1213/ANE.0000000000002670.

  PMID: 29200077 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

• 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

• 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

• Herbstreit F, Peters J, Eikermann M. Impaired upper airway integrity by residual neuromuscular blockade: increased airway collapsibility and blunted genioglossus muscle activity in response to negative pharyngeal pressure. Anesthesiology. 2009 Jun;110(6):1253-60. doi: 10.1097/ALN.0b013e31819faa71.

  PMID: 19417617 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

• Arbous 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.

  PMID: 15681938 BACKGROUND

• Sundman 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.

  PMID: 10754616 BACKGROUND

• Ledowski T, Hillyard S, O'Dea B, Archer R, Vilas-Boas F, Kyle B. Introduction of sugammadex as standard reversal agent: Impact on the incidence of residual neuromuscular blockade and postoperative patient outcome. Indian J Anaesth. 2013 Jan;57(1):46-51. doi: 10.4103/0019-5049.108562.

  PMID: 23716766 BACKGROUND

• Murphy 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.

  PMID: 18635478 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

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

Study Officials

• Béla Fülesdi, MD, Phd, DSc

  Department of Anesthesiology and Intensive Care University of Debrecen

  STUDY DIRECTOR

Central Study Contacts

György NAGY, MD

CONTACT

+36304354064; gynagy1986@gmail.com

Erzsébet Igbonu-Nagy, BSC

CONTACT

+36203991551; igbonu.nagyboske@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, Division of General, Vascular and Thoracic Anesthesia

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 15, 2024
• Study Start: October 18, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

HU (2)