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OpenTrials
Completed

NCT Number: NCT05149872

The Breath-2 Trial

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

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Key information

Conditions

Peripheral Chemosensitivity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Leiden Medical University

Leiden, South Holland, 2333ZA, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Muscle relaxation

Other

Rocuronium will be used to induce partial paralysis

Reversal

Other

Sugamamdex will be used to reverse muscle relaxation

Primary outcomes

  1. Carotid body function after full recovery of neuromuscular block

    Time frame: 40 minutes after full recovery of neuromuscular block

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

Secondary outcomes

  1. Carotid body function at symptomatic neuromuscular block

    Time frame: 5 minutes after stable partial neuromuscular block

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

  2. Carotid body function at full recovery of NMB symptoms

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

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

  3. Carotid body function after full recovery of neuromuscular block

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

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

  4. Carotid body function after full recovery of neuromuscular block

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

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

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study title

Recovery of Carotid Body Function After Full Recovery Neuromuscular Block

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Dec 8, 2021
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.