The BREATH 2 trial

Recovery of carotid body function after full recovery neuromuscular block

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000057-27-NL

Enrollment

Registered

2020-02-11

Start date

2021-10-27

Completion date

Unknown

Last updated

2021-11-03

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

Conditions

Postoperative ventilatory control

Interventions

Trade Name: Rocuronium bromide Pharmaceutical Form: Solution for infusion Trade Name: Bridion Product Name: Sugammadex Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age> 18 years old Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the time needed for full recovery of carotid body response to hypoxia (ie. hypoxic ventilatory response, HVR) after full recovery of neuromuscular block (from TOF ratio 0.7) with and without reversal with sugammadex;Secondary Objective: To evaluate the dynamics of carotid body function at different levels of NMB and during recovery.;Primary end point(s): The primary end-point is the time difference to full recovery of the hypoxic ventilatory response after full recovery of NMB between experiment 2 and 3 (ie. recovery of NMB at TOFR 0.7 without and with sugammadex 2 mg/kg).;Timepoint(s) of evaluation of this end point: During experiment, after reaching TOF ratio 1.0	—

Measure

Time frame

Main Objective: To study the time needed for full recovery of carotid body response to hypoxia (ie. hypoxic ventilatory response, HVR) after full recovery of neuromuscular block (from TOF ratio 0.7) with and without reversal with sugammadex;Secondary Objective: To evaluate the dynamics of carotid body function at different levels of NMB and during recovery.;Primary end point(s): The primary end-point is the time difference to full recovery of the hypoxic ventilatory response after full recovery of NMB between experiment 2 and 3 (ie. recovery of NMB at TOFR 0.7 without and with sugammadex 2 mg/kg).;Timepoint(s) of evaluation of this end point: During experiment, after reaching TOF ratio 1.0

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoint is the relationship between depth of NMB and carotid body function. Carotid body function will be calculated as was described in our previous publication (see Broens et al. statistical analysis section, calculation of carotid body index). Briefly, the hypoxic ventilatory response will be divided by the hypercapnic ventilatory response to correct for central ventilation. Carotid body function relative to baseline values will be evaluated at TOFR 0.7, 0.9, 1.0 and every 10 minutes hereafter until full recovery. Carotid body function will be related to depth of NMB and time; this will give an indication of the dynamics of CB inhibition at stable NMB and during recovery of NMB. In addition, we will assess how sugammadex affects the dynamic recovery of CB function. ;Timepoint(s) of evaluation of this end point: Druing experiment at stable NMB and after reaching TOF ratio 1.0	—

Measure

Time frame

Secondary end point(s): Secondary endpoint is the relationship between depth of NMB and carotid body function. Carotid body function will be calculated as was described in our previous publication (see Broens et al. statistical analysis section, calculation of carotid body index). Briefly, the hypoxic ventilatory response will be divided by the hypercapnic ventilatory response to correct for central ventilation. Carotid body function relative to baseline values will be evaluated at TOFR 0.7, 0.9, 1.0 and every 10 minutes hereafter until full recovery. Carotid body function will be related to depth of NMB and time; this will give an indication of the dynamics of CB inhibition at stable NMB and during recovery of NMB. In addition, we will assess how sugammadex affects the dynamic recovery of CB function. ;Timepoint(s) of evaluation of this end point: Druing experiment at stable NMB and after reaching TOF ratio 1.0

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Countries

Netherlands

Contacts

Public ContactMartijn Boon

LUMC

0031715262306

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026