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. 2017 Aug 14;2017(8):CD012763. doi: 10.1002/14651858.CD012763

NCT02845375.

Trial name or title Effect of neuromuscular blockade and reversal on breathing (BREATH)
Methods Allocation: randomized
Endpoint classification: pharmacodynamics study
Intervention model: parallel assignment
Masking: double‐blind (participant, investigator, outcomes assessor)
Primary purpose: treatment
Participants Estimated enrolment: 30
Inclusion criteria:

  • Male gender

  • Age 18 years and older

  • BMI < 30 kg/m2


Exclusion criteria:

  • Known or suspected neuromuscular disorders impairing neuromuscular function

  • Allergy to muscle relaxants, anaesthetics, or narcotics

  • (Family) history of malignant hyperthermia or any other muscle disease

  • Any medical, neurological, or psychiatric illness (including a history of anxiety)
Interventions Placebo will be administered following a period of muscle relaxation after which respiratory measurements will be obtained
Neostigmine will be administered following a period of muscle relaxation after which respiratory measurements will be obtained
Sugammadex will be administered following a period of muscle relaxation after which respiratory measurements will be obtained
Outcomes Primary outcome measures:

  • Ventilatory responses [Time Frame: during the 1 to 2 hours following reversal] [Designated as safety issue: no] Investigators will apply hypoxic and hypercapnic challenges and will measure ventilation on a breath‐to‐breath basis using the dynamic end‐tidal forcing (DEF) technique. This technique allows manipulation of inspired gas concentrations to steer end‐tidal concentrations of oxygen and carbon dioxide (CO2) independent of the ventilatory response, or concentrations of O2 and CO2 in mixed venous blood. The technique allows reliable assessment of carotid body function (in this case, hypoxia) without the confounding effects of variations in end‐tidal CO2. Additionally, investigators will obtain the ventilatory response to hypercapnia at hyperoxic conditions. This allows assessment of the response activity of central chemoreceptors in the brainstem
Starting date September 2016
Contact information Leiden University Medical Center, Leiden, ZH, Netherlands, 2333 ZA
Notes This study is not yet open for participant recruitment