Actively Recruiting

Age: 18Years - 65Years
All Genders
ID06544980

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

Led by Tamas Vegh, MD · Updated on 2024-08-12

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how the size of the retroglossal pharyngeal airway changes after patients are extubated compared to before muscle relaxation during surgery. They aim to understand the relationship between residual muscle relaxation and airway area, which is important because leftover muscle weakness after surgery can cause breathing problems. This observational study involves patients undergoing surgery with anesthesia where muscle relaxant monitoring is usually not done by the anesthetist. During surgery, anesthesia including muscle relaxants is given based on clinical signs without neuromuscular monitoring by the anesthetist. An independent anesthesiologist continuously monitors muscle relaxant effects using an electromyograph without sharing results with the anesthetist. After surgery, pharyngoscopies are performed before muscle relaxants and after extubation to measure airway areas. If muscle relaxation is still present below a certain threshold, rescue medication to reverse the muscle relaxant may be given. Participants are monitored throughout surgery with standard vital sign devices and neuromuscular monitoring. The study compares airway areas measured during inspiration and expiration at different times and muscle relaxation levels. Data are analyzed statistically to find significant changes. The overall participation includes anesthesia, surgeries lasting at least 30 minutes, airway imaging before and after extubation, and muscle relaxation monitoring. The study ends after collecting and analyzing these measurements.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years
  • ASA physical status 1 to 3
  • Normal body weight with BMI between 18.5 and 25
  • Equal proportion of men and women
  • Surgery lasting at least 30 minutes
  • Surgery requiring intratracheal intubation
  • Patients in supine position during surgery
Not Eligible

You will not qualify if you...

  • Diseases affecting neuromuscular function such as myopathies or severe liver and kidney failure
  • Use of drugs that affect neuromuscular function like magnesium or aminoglycosides
  • Difficult airway or expected difficult intubation
  • Pregnancy or breastfeeding
  • Acute surgery
  • Chronic obstructive pulmonary disease (COPD)
  • Glaucoma

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Duration of surgery (at least 30 minutes)

Participants undergo routine anaesthesia and surgery during which continuous neuromuscular monitoring is performed by an independent anaesthesiologist without affecting the clinical care.

1 visit during surgery (in-person)

Diagnostic Evaluation

Duration - Same day as surgery

Pharyngoscopy and measurement of upper airway cross-sectional areas are performed before muscle relaxant administration and after extubation to assess airway changes.

2 assessments during surgery day (in-person)

Post-operative Follow-up

Duration - Short period immediately after surgery

If necessary, rescue medication is administered after extubation based on neuromuscular monitoring results to reverse residual muscle relaxation.

1 visit after surgery (in-person)

Trial Site Locations

Total: 1 location

1

University of Debrecen

Debrecen, Hajdú-Bihar, Hungary, 4008

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Research Team

L

László Asztalos, MD, PhD

E

Erzsébet Igbonu-Nagy, BSC

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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The incidence and mechanisms of pharyngeal and upper esophageal dysfunction in partially paralyzed humans: pharyngeal videoradiography and simultaneous manometry after atracurium.

E Sundman, H Witt, R Olsson...

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Impaired upper airway integrity by residual neuromuscular blockade: increased airway collapsibility and blunted genioglossus muscle activity in response to negative pharyngeal pressure.

Frank Herbstreit, Jürgen Peters, Matthias Eikermann

https://pubmed.ncbi.nlm.nih.gov/19417617

Post-anaesthesia pulmonary complications after use of muscle relaxants (POPULAR): a multicentre, prospective observational study.

Eva Kirmeier, Lars I Eriksson, Heidrun Lewald...

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Use of a train-of-four ratio of 0.95 versus 0.9 for tracheal extubation: an exploratory analysis of POPULAR data.

Manfred Blobner, Jennifer M Hunter, Claude Meistelman...

https://pubmed.ncbi.nlm.nih.gov/31607388

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.

Tom Heier, James E Caldwell, John R Feiner...

https://pubmed.ncbi.nlm.nih.gov/20808216

Impact of reversal strategies on the incidence of postoperative residual paralysis after rocuronium relaxation without neuromuscular monitoring: A partially randomised placebo controlled trial.

Réka Nemes, Béla Fülesdi, Adrienn Pongrácz...

https://pubmed.ncbi.nlm.nih.gov/28030444