The Breath-2 Trial

Phase 4

Completed

• Conditions: Peripheral Chemosensitivity
• Interventions: Other: Muscle relaxation; Other: Reversal

• Registration Number: NCT05149872
• Lead Sponsor: Leiden University Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-12-07
• Study First Posted: 2021-12-08
• Study Start: 2022-08-15
• Primary Completion: 2022-11-01
• Study Completion: 2023-04-01
• Status Verified: 2024-10
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TOF ratio 0.7 spontaneous recovery	Muscle relaxation	TOF ratio maintained at 0.7, spontaneous recovery
TOF ratio 0.7 low dose sugammadex	Muscle relaxation	TOF ratio maintained at 0.7, reversal with sugammadex 2 mg/kg
TOF ratio 0.9 spontaneous recovery	Muscle relaxation	TOF ratio maintained at 0.9, spontaneous recovery
TOF ratio 0.7 high dose sugammadex	Muscle relaxation	TOF ratio maintained at 0.7, reversal with sugammadex 4 mg/kg
TOF ratio 0.7 high dose sugammadex	Reversal	TOF ratio maintained at 0.7, reversal with sugammadex 4 mg/kg
TOF ratio 0.7 low dose sugammadex	Reversal	TOF ratio maintained at 0.7, reversal with sugammadex 2 mg/kg

Primary Outcome Measures

Name	Time	Method
Carotid body function after full recovery of neuromuscular block	40 minutes after full recovery of neuromuscular block	Carotid body function will be determined by measuring acute hypoxic ventilatory response

Secondary Outcome Measures

Name	Time	Method
Carotid body function at symptomatic neuromuscular block	5 minutes after stable partial neuromuscular block	Carotid body function will be determined by measuring acute hypoxic ventilatory response
Carotid body function after full recovery of neuromuscular block	40 minutes after full recovery of neuromuscular block symptoms	Carotid body function will be determined by measuring acute hypoxic ventilatory response
Carotid body function at full recovery of NMB symptoms	0 minutes after full recovery of neuromuscular block symptoms	Carotid body function will be determined by measuring acute hypoxic ventilatory response

Trial Locations

Locations (1)

Leiden Medical University; 🇳🇱 Leiden, Zuid Holland, Netherlands