The Breath-2 Trial

Study Overview
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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

Official Title
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Recovery of Carotid Body Function After Full Recovery Neuromuscular Block

Conditions
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Peripheral Chemosensitivity

Intervention / Treatment
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* Other: Muscle relaxation
* Other: Reversal


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TOF ratio 0.9 spontaneous recovery<br>TOF ratio maintained at 0.9, spontaneous recovery | Other: Muscle relaxation<br>* Rocuronium will be used to induce partial paralysis<br>|
| Other: TOF ratio 0.7 spontaneous recovery<br>TOF ratio maintained at 0.7, spontaneous recovery | Other: Muscle relaxation<br>* Rocuronium will be used to induce partial paralysis<br>|
| Other: TOF ratio 0.7 low dose sugammadex<br>TOF ratio maintained at 0.7, reversal with sugammadex 2 mg/kg | Other: Muscle relaxation<br>* Rocuronium will be used to induce partial paralysis<br>Other: Reversal<br>* Sugamamdex will be used to reverse muscle relaxation<br>|
| Other: TOF ratio 0.7 high dose sugammadex<br>TOF ratio maintained at 0.7, reversal with sugammadex 4 mg/kg | Other: Muscle relaxation<br>* Rocuronium will be used to induce partial paralysis<br>Other: Reversal<br>* Sugamamdex will be used to reverse muscle relaxation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid body function after full recovery of neuromuscular block | Carotid body function will be determined by measuring acute hypoxic ventilatory response | 40 minutes after full recovery of neuromuscular block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid body function at partial neuromuscular block TOF ratio 0.7 | Carotid body function will be determined by measuring acute hypoxic ventilatory response | 5 minutes after stable partial neuromuscular block | 
| Carotid body function at partial neuromuscular block TOF ratio 0.9 | Carotid body function will be determined by measuring acute hypoxic ventilatory response | 5 minutes after stable partial neuromuscular block | 
| Carotid body function at full recovery TOF ratio 1.0 | Carotid body function will be determined by measuring acute hypoxic ventilatory response | 0 minutes after full recovery of neuromuscular block | 
| Carotid body function after full recovery of neuromuscular block | Carotid body function will be determined by measuring acute hypoxic ventilatory response | 20 minutes after full recovery of neuromuscular block |