The Breath-2 Trial

Leiden University Medical Center (LUMC)

Status and phase: Completed; Phase 4

Conditions: Peripheral Chemosensitivity

Treatments: Other: Muscle relaxation; Other: Reversal

Study type: Interventional

Funder types: Other

Identifiers

NCT05149872

P21.083

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 3 patient groups

spontaneous recovery

Other group

Description:

Spontaneous recovery

Treatment:

Other: Muscle relaxation

reversal with sugammadex 2 mg/kg

Other group

Description:

reversal with sugammadex 2 mg/kg

Treatment:

Other: Reversal

Other: Muscle relaxation

reversal with sugammadex 4 mg/kg

Other group

Description:

reversal with sugammadex 4 mg/kg

Treatment:

Other: Reversal

Other: Muscle relaxation