Respiratory Insufficiency Clinical Trial
— BREATHOfficial title:
Effect of Neuromuscular Blockade and Reversal by Sugammadex Versus Neostigmine on Breathing When Hypoxic or Hypercapnic in Volunteers
Verified date | February 2020 |
Source | Leiden University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study the investigators will assess (i) the effect of partial neuromuscular blockade
(NMB; TOF ratio 0.8 and 0.6) induced by low-dose rocuronium on the ventilatory response to
isocapnic hypoxia and (ii) the effect over time (from TOF 0.6 to TOF 1.0) of the reversal by
sugammadex, neostigmine or placebo in healthy volunteers.
Additionally the investigators will assess the effect of partial NMB (TOF ratio 0.6) induced
by low-dose rocuronium on the ventilatory response to hypercapnia and effect over time (from
TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy
volunteers.
Status | Completed |
Enrollment | 46 |
Est. completion date | September 1, 2018 |
Est. primary completion date | September 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - male gender - age 18 years and older - body mass index < 30 kg/m2. Exclusion Criteria: - Known or suspected neuromuscular disorders impairing neuromuscular function; - allergies to muscle relaxants, anesthetics or narcotics; - a (family) history of malignant hyperthermia or any other muscle disease; - any medical, neurological or psychiatric illness (including a history of anxiety). |
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University Medical Center | Leiden | ZH |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center |
Netherlands,
Dahan A, Nieuwenhuijs D, Teppema L. Plasticity of central chemoreceptors: effect of bilateral carotid body resection on central CO2 sensitivity. PLoS Med. 2007 Jul 24;4(7):e239. — View Citation
Eriksson LI, Lennmarken C, Wyon N, Johnson A. Attenuated ventilatory response to hypoxaemia at vecuronium-induced partial neuromuscular block. Acta Anaesthesiol Scand. 1992 Oct;36(7):710-5. — View Citation
Eriksson LI, Sato M, Severinghaus JW. Effect of a vecuronium-induced partial neuromuscular block on hypoxic ventilatory response. Anesthesiology. 1993 Apr;78(4):693-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response) | The change in breathing response to a decrease in inspired oxygen concentration, which equals the isocapnic ventilatory response to hypoxia. | during the 1-2 hours following reversal | |
Primary | Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response) | The ventilatory response to a decrease in oxygen saturaytion of 80% | 0-10 minutes following reversal |
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