Phase 4
N=18
The Effects of General Anesthetics on Upper Airway Collapsibility in Healthy Subjects
Airway Complication of Anaesthesia · Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01557920 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Upper Airway Closing Pressure — -9.83; -10.77 cm H20
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Propofol (Drug); Sevoflurane (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Upper Airway Closing Pressure |
-9.83; -10.77 | — |
| PRIMARY Proportion of Pathological Swallows |
25.9; 4.9; 15.8; 34.9; 1.0; 13.2 | 0.001 sig |
| SECONDARY Airway Diameter |
— | — |
| SECONDARY Genioglossus Muscle Electromyogram |
32.8; 24.2; 26.0; 22.3 | — |
| SECONDARY Minute Ventilation (Tidal Volume and Respiratory Rate) |
7.9; 6.7; 5.6; 7.2; 5.7 | — |
| SECONDARY Duty Cycle |
42; 42; 43; 40; 41 | — |
Summary
The investigators hypothesize that propofol, when compared to sevoflurane, causes the upper airway to collapse more easily and causes less activity in the tongue muscle. Additionally, the investigators hypothesize that, under increased carbon dioxide concentrations of the air inhaled, the upper airway will be less likely to collapse under anesthesia and there will be increased activity in the tongue muscle under both propofol and sevoflurane, when compared to breathing normal concentrations of carbon dioxide, as in room air. Furthermore the investigators hypothesize that anesthesia disrupt the breathing swallow coordination, an effect additionally altered by increased carbon dioxide through increased respiratory drive.
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists (ASA) class I
- Age between 18 and 45
- BMI 18-28 kg/m^2
Exclusion Criteria
- Concurrent significant medical illness (heart disease including untreated hypertension, Clinically significant kidney disease, liver disease, or lung disease, History of myasthenia gravis or other muscle and nerve disease)
- Anxiety disorder requiring treatment
- Concurrent medications known to affect anesthesia, upper airway muscles or respiratory function (e.g., gabaergic anxiolytics, antipsychotics)
- Individuals with a history of allergy or adverse reaction to lidocaine, propofol, or sevoflurane
- For women: pregnancy
- Suggestion of obstructive sleep apnea (OSA) or any other sleep disorder (e.g. witnessed apneas, gasping or choking during sleep, unexplained excessive daytime sleepiness)
- History of drug or alcohol abuse
- Acute intermittent porphyria
Data sourced from ClinicalTrials.gov (NCT01557920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.