Respiratory-Gated Imaging Techniques Clinical Trial
Official title:
Visualization of Regional Lung Ventilation During Neostigmine or Sugammadex Enhanced Recovery From Moderate Residual Neuromuscular Blockade in the Anaesthetized Rat Using Functional Respiratory Imaging
The use of neuromuscular blocking agents (NMBAs) is still associated with postoperative
pulmonary complications. The investigators rely on acceleromyography (AMG) of a peripheral
nerve/muscle to assess the patients' breathing capability at the end of surgery. It is
possible that respiratory complications after surgery (e.g. desaturation and atelectasis)
are related to the lack of diaphragm activity.
A previous trial by our study group links the use of sugammadex, a novel selective relaxant
binding agent (SRBA) for reversal of neuromuscular blockade, to an increase in diaphragm
electrical activity, compared to reversal with neostigmine. Our hypothesis is that by making
nicotinergic acetylcholine receptors free from rocuronium in the diaphragmatic neuromuscular
junctions, instead of increasing the amount of acetylcholine (like neostigmine does),
sugammadex will result in a better neuromuscular coupling. This may have its subsequent
effects on the central control of breathing, influencing the balance between intercostal and
diaphragm activity.
The investigators now propose a study in rats, where the investigators will use Functional
Respiratory Imaging (FRI, property of FluidDA n.v., Groeningenlei 132, B-2550 Kontich) to
assess regional lung ventilation after sugammadex, neostigmine or spontaneous reversal. The
images obtained through micro-CT scans allow us to accurately reconstruct airway morphology
in the free-breathing rat. It will provide us with new insights into breathing physiology
after reversal of neuromuscular blockade.
This study is designed to assess the effect of sugammadex, neostigmine/glycopyrrolate and
spontaneous reversal of a moderate rocuronium-induced neuromuscular blockade on regional
lung ventilation. This is a randomized, controlled, parallel-group double blind trial in
rats. A total of 18 adult male Sprague-Dawley rats will be used, 6 in each treatment group.
The animals will be randomized in one of three groups, in a 1:1:1 ratio. This randomization
will be performed according to a computer-generated randomization list. The first group will
receive neostigmine/glycopyrrolate. The second group will receive sugammadex. The third
group will receive water for injection. Reversal agents will be administered at a
train-of-four (TOF) of 0.5, as measured with AMG.
The investigators will assess regional ventilation by means of micro-CT scanning during
spontaneous breathing after the TOF ratio has reached ≥ 0.9. This way, the investigators can
accurately reconstruct airway morphology. The different airway sections can then be linked
to the corresponding lung tissue, and a full anatomical picture is thus rendered. A
comparison of morphological scans at different breathing levels (e.g. end-inspiratory and
end-expiratory) will allow us to model breath-by-breath regional airway and alveolar
recruitment.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment