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The Breath-2 Trial

Recovery of Carotid Body Function After Full Recovery Neuromuscular Block

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05149872
Enrollment
35
Registered
2021-12-08
Start date
2022-08-15
Completion date
2023-04-01
Last updated
2025-02-11

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

Conditions

Peripheral Chemosensitivity

Brief summary

This is a randomized, cross over, experimental trial in which carotid body function will be evaluated in 35 healthy subjects during partial muscle relaxation and after recovery from muscle relaxation

Interventions

OTHERMuscle relaxation

Rocuronium will be used to induce partial paralysis

OTHERReversal

Sugamamdex will be used to reverse muscle relaxation

Sponsors

Leiden University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\* age \> 18 years

Exclusion criteria

* BMI index \> 30 kg/m2 * 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 neurological or psychiatric illness (including a history of anxiety). * ASA class 3 or higher * Gastro-oesophageal regurgitation

Design outcomes

Primary

MeasureTime frameDescription
Carotid body function after full recovery of neuromuscular block40 minutes after full recovery of neuromuscular blockCarotid body function will be determined by measuring acute hypoxic ventilatory response

Secondary

MeasureTime frameDescription
Carotid body function at symptomatic neuromuscular block5 minutes after stable partial neuromuscular blockCarotid body function will be determined by measuring acute hypoxic ventilatory response
Carotid body function at full recovery of NMB symptoms0 minutes after full recovery of neuromuscular block symptomsCarotid body function will be determined by measuring acute hypoxic ventilatory response
Carotid body function after full recovery of neuromuscular block20 minutes after full recovery of neuromuscular block symptomsCarotid body function will be determined by measuring acute hypoxic ventilatory response

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026