The Breath-2 Trial

NCT ID: NCT05149872

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-04-01

Brief Summary

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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

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Conditions

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Peripheral Chemosensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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spontaneous recovery

Spontaneous recovery

Group Type OTHER

Muscle relaxation

Intervention Type OTHER

Rocuronium will be used to induce partial paralysis

reversal with sugammadex 2 mg/kg

reversal with sugammadex 2 mg/kg

Group Type OTHER

Muscle relaxation

Intervention Type OTHER

Rocuronium will be used to induce partial paralysis

Reversal

Intervention Type OTHER

Sugamamdex will be used to reverse muscle relaxation

reversal with sugammadex 4 mg/kg

reversal with sugammadex 4 mg/kg

Group Type OTHER

Muscle relaxation

Intervention Type OTHER

Rocuronium will be used to induce partial paralysis

Reversal

Intervention Type OTHER

Sugamamdex will be used to reverse muscle relaxation

Interventions

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Muscle relaxation

Rocuronium will be used to induce partial paralysis

Intervention Type OTHER

Reversal

Sugamamdex will be used to reverse muscle relaxation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Martijn Boon

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Leiden Medical University

Leiden, South Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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P21.083

Identifier Type: -

Identifier Source: org_study_id

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