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CompletedNCT05149872Updated Feb 11, 2025

The Breath-2 Trial

A Phase 4 interventional study of Muscle relaxation and Reversal in Peripheral Chemosensitivity, sponsored by Leiden University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-11.

Sponsored by Leiden University Medical Center · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Peripheral Chemosensitivity
03

In context

Lead sponsor

Leiden University Medical Center is the lead sponsor of 326 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

* age > 18 years

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
  • Gastro-oesophageal regurgitation
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
35 participants (actual)

Study arms

  • Other
    spontaneous recovery

    Spontaneous recovery

    Other: Muscle relaxation

  • Other
    reversal with sugammadex 2 mg/kg

    reversal with sugammadex 2 mg/kg

    Other: Muscle relaxation · Other: Reversal

  • Other
    reversal with sugammadex 4 mg/kg

    reversal with sugammadex 4 mg/kg

    Other: Muscle relaxation · Other: Reversal

Interventions

  • OtherMuscle relaxation

    Rocuronium will be used to induce partial paralysis

  • OtherReversal

    Sugamamdex will be used to reverse muscle relaxation

06

What researchers measure

Primary outcomes

  1. Carotid body function after full recovery of neuromuscular block

    Carotid body function will be determined by measuring acute hypoxic ventilatory response

    Time frame: 40 minutes after full recovery of neuromuscular block

Secondary outcomes

  1. Carotid body function at symptomatic neuromuscular block

    Carotid body function will be determined by measuring acute hypoxic ventilatory response

    Time frame: 5 minutes after stable partial neuromuscular block

  2. Carotid body function at full recovery of NMB symptoms

    Carotid body function will be determined by measuring acute hypoxic ventilatory response

    Time frame: 0 minutes after full recovery of neuromuscular block symptoms

  3. Carotid body function after full recovery of neuromuscular block

    Carotid body function will be determined by measuring acute hypoxic ventilatory response

    Time frame: 20 minutes after full recovery of neuromuscular block symptoms

  4. Carotid body function after full recovery of neuromuscular block

    Carotid body function will be determined by measuring acute hypoxic ventilatory response

    Time frame: 40 minutes after full recovery of neuromuscular block symptoms

07

Study locations

1 site
  • Leiden Medical University
    Leiden, Zuid Holland 2333ZA, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05149872
Lead sponsor
Leiden University Medical Center
Responsible party
Martijn Boon (MD PhD, Leiden University Medical Center) — Principal investigator
First posted
Dec 8, 2021
Start date
Aug 15, 2022
Primary completion
Nov 1, 2022
Completion
Apr 1, 2023
Last update
Feb 11, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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