Functional Respiratory Imaging After Neostigmine or Sugammadex
Information source: Onze Lieve Vrouw Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Respiratory-Gated Imaging Techniques
Intervention: Neostigmine (Drug); Sugammadex (Drug); Water for injection (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Onze Lieve Vrouw Hospital Official(s) and/or principal investigator(s): GUY CAMMU, MD, PhD, Principal Investigator, Affiliation: OLV Hospital, Aalst, Belgium
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Regional lung ventilation assessed by means of micro-CT scanning during spontaneous breathing after recovery from neuromuscular block.
Secondary outcome: Tidal volume (TV, mL) of breaths recorded by means of micro-CT scanning during spontaneous breathing after recovery from neuromuscular block.
Detailed description:
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.
Eligibility
Minimum age: 3 Months.
Maximum age: 6 Months.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- male Sprague-Dawley rats
Exclusion Criteria:
- N/A
Locations and Contacts
OLV Hospital, Aalst 9300, Belgium
Additional Information
Related publications: Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. Cammu GV, Smet V, De Jongh K, Vandeput D. A prospective, observational study comparing postoperative residual curarisation and early adverse respiratory events in patients reversed with neostigmine or sugammadex or after apparent spontaneous recovery. Anaesth Intensive Care. 2012 Nov;40(6):999-1006. Grosse-Sundrup M, Henneman JP, Sandberg WS, Bateman BT, Uribe JV, Nguyen NT, Ehrenfeld JM, Martinez EA, Kurth T, Eikermann M. Intermediate acting non-depolarizing neuromuscular blocking agents and risk of postoperative respiratory complications: prospective propensity score matched cohort study. BMJ. 2012 Oct 15;345:e6329. doi: 10.1136/bmj.e6329. Schepens T, Cammu G, Saldien V, De Neve N, Jorens PG, Foubert L, Vercauteren M. Electromyographic activity of the diaphragm during neostigmine or sugammadex-enhanced recovery after neuromuscular blockade with rocuronium: a randomised controlled study in healthy volunteers. Eur J Anaesthesiol. 2015 Jan;32(1):49-57. doi: 10.1097/EJA.0000000000000140. De Backer JW, Vos WG, Burnell P, Verhulst SL, Salmon P, De Clerck N, De Backer W. Study of the variability in upper and lower airway morphology in Sprague-Dawley rats using modern micro-CT scan-based segmentation techniques. Anat Rec (Hoboken). 2009 May;292(5):720-7. doi: 10.1002/ar.20877. Eikermann M, Zaremba S, Malhotra A, Jordan AS, Rosow C, Chamberlin NL. Neostigmine but not sugammadex impairs upper airway dilator muscle activity and breathing. Br J Anaesth. 2008 Sep;101(3):344-9. doi: 10.1093/bja/aen176. Epub 2008 Jun 16.
Starting date: December 2014
Last updated: April 20, 2015
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