The BREATH study

Effect of neuromuscular blockade and reversal by sugammadex versus neostigmine on breathing when hypoxic or hypercapnic in volunteers

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27296

Enrollment

Registered

2017-05-04

Start date

2017-06-06

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid bodies

Interventions

- Partial neuromuscular block with rocuronium - Hypoxic and hypercapnic ventilatoy respons - Antagonizing neuromuscular block with either neostigmine or sugammadex or placebo

Eligibility

Inclusion criteria

Inclusion criteria: Healthy male volunteers aged 18 and older with a body mass index < 30 kg/m2.

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
- 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 the effect over time (from TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy volunteers	—

Secondary

Measure	Time frame
To 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.	—

Contacts

Public ContactAlbert Dahan

Leiden University Medical Center (LUMC), Department of Anesthesiology, P.O. Box 9600

a.dahan@lumc.nl+31 (0)71 5262301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)