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Functional Respiratory Imaging After Neostigmine or Sugammadex (FRINeoS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284412
First Posted: November 6, 2014
Last Update Posted: April 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Universiteit Antwerpen
MSD Belgium BVBA
Information provided by (Responsible Party):
Guy CAMMU, Onze Lieve Vrouw Hospital
  Purpose

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.


Condition Intervention Phase
Respiratory-Gated Imaging Techniques Drug: Neostigmine Drug: Sugammadex Drug: Water for injection Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Guy CAMMU, Onze Lieve Vrouw Hospital:

Primary Outcome Measures:
  • Regional lung ventilation assessed by means of micro-CT scanning during spontaneous breathing after recovery from neuromuscular block. [ Time Frame: CT scanning will take between 5 to 8 minutes, followed by post-processing of the images. ]
    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.


Secondary Outcome Measures:
  • Tidal volume (TV, mL) of breaths recorded by means of micro-CT scanning during spontaneous breathing after recovery from neuromuscular block. [ Time Frame: CT scanning will take between 5 to 8 minutes, followed by post-processing of the images. ]
    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.


Enrollment: 13
Study Start Date: December 2014
Study Completion Date: April 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: neostigmine
Neostigmine will be dosed as 60 μg/kg, and glycopyrrolate 12 μg/kg (commercially available 5:1 co-formulation), as a single iv bolus administered over 10sec, for reversal of rocuronium-induced moderate neuromuscular blockade.
Drug: Neostigmine
At a train-of-four (TOF) ratio of 0.5: administration of neostigmine 0.06 mg/kg for reversal of neuromuscular blockade.
Other Name: Robinul-Neostigmine
Experimental: Sugammadex
Sugammadex will be dosed 15 mg/kg, as a single iv bolus administered over 10sec, for reversal of rocuronium-induced moderate neuromuscular blockade.
Drug: Sugammadex
At a train-of-four (TOF) ratio of 0.5: administration of sugammadex 15 mg/kg for reversal of neuromuscular blockade.
Other Name: Bridion
Placebo Comparator: Water for injection
Water will be dosed arbitrarily as a 1 mL single iv bolus administered over 10sec.
Drug: Water for injection
At a train-of-four (TOF) ratio of 0.5: administration of placebo for spontaneous recovery of neuromuscular blockade.
Other Name: Aqua ad iniectabilia

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

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Ages Eligible for Study:   3 Months to 6 Months   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male Sprague-Dawley rats

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284412


Locations
Belgium
OLV Hospital
Aalst, Belgium, 9300
Sponsors and Collaborators
Onze Lieve Vrouw Hospital
Universiteit Antwerpen
MSD Belgium BVBA
Investigators
Principal Investigator: GUY CAMMU, MD, PhD OLV Hospital, Aalst, Belgium
  More Information

Publications:

Responsible Party: Guy CAMMU, MD, PhD, Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier: NCT02284412     History of Changes
Other Study ID Numbers: TSGC02
First Submitted: October 28, 2014
First Posted: November 6, 2014
Last Update Posted: April 21, 2015
Last Verified: April 2015

Keywords provided by Guy CAMMU, Onze Lieve Vrouw Hospital:
Neostigmine
Sugammadex

Additional relevant MeSH terms:
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents