Measuring Upper Airway Cross Sectional Areas During Residual Neuromuscular Blockade and After Reserval

NCT06544980 | Recruiting DMC

• 3 other identifiers: AITT/2022/5OGYEI/3962-11-/2023DE RKEB/IKEB:625-2022
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In our study, the investigators sought to answer the question of how the retroglossal pharyngeal areas measured after extubation of patients compare to baseline (before muscle relaxation) values. The investigators also investigated how these areas change as a function of TOF ratios measured at extubation, thus looking for a correlation between residual muscle relaxant effect and airway area.

Conditions

Postoperative Residual Curarization; Airway Obstruction on Anaesthetic Emergence

Keywords

residual neuromuscular blockade; postoperative airway obstruction; electromyography

Outcome Measures

Primary Outcomes (1)

• The differences in retroglossal pharyngeal cross sectional areas (inspiration and exspiration) measured at different TOF values

  The differences in retroglossal pharyngeal cross sectional areas (inspiration and exspiration) measured at different train of four TOF values, and changes in these values compared to (initial) retroglossae pharyngeal areas detected before administration of muscle relaxants. Areas are measured in pixels and the rate of reduction of areas is expressed as a percentage.

  before intubation, after extubation of the trachea

Eligibility Criteria

• Age: 18 Years - 65 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: 18-65 years;
• ASA 1-3;
• BMI 18.5-25 (normal body weight);
• men/women in equal proportion;
• duration of surgeries at least ≥ 30 minutes;
• intervention requiring intratracheal intubation;
• patients are in a supine position.

You may not qualify if:

• diseases affecting neuromuscular function (myopathies, severe liver and kidney failure);
• drugs affecting neuromuscular function (magnesium, aminoglycosides);
• difficult airway, expected difficult intubation;
• pregnancy (pregnancy test for women of childbearing age to rule out pregnancy we finish);
• breastfeeding;
• acute surgery;
• COPD
• glaucoma

Sponsors & Collaborators

• Tamas Vegh, MD: lead

Study Sites (1)

University of Debrecen

Debrecen, Hajdú-Bihar, 4008, Hungary

RECRUITING

Related Publications (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Heier T, Caldwell JE, Feiner JR, Liu L, Ward T, Wright PM. Relationship between normalized adductor pollicis train-of-four ratio and manifestations of residual neuromuscular block: a study using acceleromyography during near steady-state concentrations of mivacurium. Anesthesiology. 2010 Oct;113(4):825-32. doi: 10.1097/ALN.Ob013e3181ebddca.

  PMID: 20808216 BACKGROUND

• 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

• 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

• 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

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

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

Study Officials

• László Asztalos, MD, PhD

  Department of Anesthesiology and Intensive Care University of Debrecen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

László Asztalos, MD, PhD

CONTACT

+36307371315; asztaloslasz@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: August 5, 2024
• First Posted: August 9, 2024
• Study Start: January 2, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

HU (1)