Peripheral ChemosensitivityPhase 4NCT05149872
The Breath-2 Trial
A Phase 4 study testing Muscle relaxation and Reversal in people with Peripheral Chemosensitivity, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Chemosensitivity
- What is being tested?
- Muscle relaxation and Reversal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Aug 2022to 1 Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age > 18 years
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Recovery of Carotid Body Function After Full Recovery Neuromuscular Block
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
- Conditions
- Peripheral Chemosensitivity
- Being tested
- Muscle relaxation, Reversal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle relaxationOther
Rocuronium will be used to induce partial paralysis
ReversalOther
Sugamamdex will be used to reverse muscle relaxation
| Study group | Role | What they receive |
|---|---|---|
| spontaneous recovery | Other | Spontaneous recovery Receives: Other: Muscle relaxation |
| reversal with sugammadex 2 mg/kg | Other | reversal with sugammadex 2 mg/kg Receives: Other: Muscle relaxation; Other: Reversal |
| reversal with sugammadex 4 mg/kg | Other | reversal with sugammadex 4 mg/kg Receives: Other: Muscle relaxation; Other: Reversal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid body function after full recovery of neuromuscular block
Carotid body function will be determined by measuring acute hypoxic ventilatory response
Measured: 40 minutes after full recovery of neuromuscular block
Secondary outcomes (4)
Carotid body function at symptomatic neuromuscular block
Carotid body function will be determined by measuring acute hypoxic ventilatory response
Measured: 5 minutes after stable partial neuromuscular block
Carotid body function at full recovery of NMB symptoms
Carotid body function will be determined by measuring acute hypoxic ventilatory response
Measured: 0 minutes after full recovery of neuromuscular block symptoms
Carotid body function after full recovery of neuromuscular block
Carotid body function will be determined by measuring acute hypoxic ventilatory response
Measured: 20 minutes after full recovery of neuromuscular block symptoms
Carotid body function after full recovery of neuromuscular block
Carotid body function will be determined by measuring acute hypoxic ventilatory response
Measured: 40 minutes after full recovery of neuromuscular block symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start15 Aug 2022
- Primary completion1 Nov 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral ChemosensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martijn Boon, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149872
- Sponsor's protocol ID
- P21.083
- Status last verified
- Oct 2024
- First submitted
- 9 Nov 2021
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery of Carotid Body Function After Full Recovery Neuromuscular Block
- ClinicalTrials.gov ID
- NCT05149872
- Acronym / sponsor ID
- P21.083
- Conditions
- Peripheral Chemosensitivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| spontaneous recovery | Other | Other: Muscle relaxationSpontaneous recovery |
| reversal with sugammadex 2 mg/kg | Other | Other: Muscle relaxation, Other: Reversalreversal with sugammadex 2 mg/kg |
| reversal with sugammadex 4 mg/kg | Other | Other: Muscle relaxation, Other: Reversalreversal with sugammadex 4 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age > 18 years
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle relaxationRocuronium will be used to induce partial paralysis | Other | reversal with sugammadex 2 mg/kg, reversal with sugammadex 4 mg/kg, spontaneous recovery |
| ReversalSugamamdex will be used to reverse muscle relaxation | Other | reversal with sugammadex 2 mg/kg, reversal with sugammadex 4 mg/kg |
Primary outcome
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
4 secondary outcomes
Carotid body function at symptomatic neuromuscular block
Time frame: 5 minutes after stable partial neuromuscular block
Carotid body function at full recovery of NMB symptoms
Time frame: 0 minutes after full recovery of neuromuscular block symptoms
Carotid body function after full recovery of neuromuscular block
Time frame: 20 minutes after full recovery of neuromuscular block symptoms
Carotid body function after full recovery of neuromuscular block
Time frame: 40 minutes after full recovery of neuromuscular block symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Muscle relaxation and Reversal in people with Peripheral Chemosensitivity, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid body function after full recovery of neuromuscular block (time frame: 40 minutes after full recovery of neuromuscular block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.