Phase 4
N=40
Effect of Neuromuscular Blockade and Reversal on Breathing
Respiratory Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT02845375 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response) — 0.66; 0.43; 0.54; 0.34 L/min/% desaturation
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sugammadex (Drug); Neostigmine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Leiden University Medical Center
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response) |
0.49; 0.36; 0.48 | 0.299 |
| PRIMARY Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response) |
0.49; 0.36; 0.48 | 0.299 |
Summary
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02845375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.