Respiratory-Gated Imaging Techniques Clinical Trial
— FRINeoSOfficial 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.
| Status | Completed |
| Enrollment | 13 |
| Est. completion date | April 2015 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 3 Months to 6 Months |
| Eligibility |
Inclusion Criteria: - male Sprague-Dawley rats Exclusion Criteria: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | OLV Hospital | Aalst |
| Lead Sponsor | Collaborator |
|---|---|
| Onze Lieve Vrouw Hospital | MSD Belgium BVBA, Universiteit Antwerpen |
Belgium,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Regional lung ventilation assessed by means of micro-CT scanning during spontaneous breathing after recovery from neuromuscular block. | Comparison of the effect of sugammadex, neostigmine/glycopyrrolate and spontaneous recovery on regional lung ventilation in the spontaneously breathing rat, assessed by micro-CT scanning after recovery from neuromuscular block. | CT scanning will take between 5 to 8 minutes, followed by post-processing of the images. | Yes |
| Secondary | Tidal volume (TV, mL) of breaths recorded by means of micro-CT scanning during spontaneous breathing after recovery from neuromuscular block. | Comparison of the effect of sugammadex, neostigmine/glycopyrrolate and spontaneous recovery on tidal volume of breaths in the spontaneously breathing rat, assessed by micro-CT scanning after recovery from neuromuscular block. | CT scanning will take between 5 to 8 minutes, followed by post-processing of the images. | Yes |