Inhaled Fentanyl Citrate & Dyspnea
- Registration Number
- NCT01853449
- Lead Sponsor
- McGill University
- Brief Summary
"Dyspnea" refers to the awareness of breathing discomfort that is typically experienced during exercise in health and disease. In various participant populations, dyspnea is a predictor of disability and death; and contributes to exercise intolerance and an adverse health-related quality-of-life. It follows that alleviating dyspnea and improving exercise tolerance are among the principal goals of disease management. Nevertheless, the effective management of dyspnea and activity-limitation remains an elusive goal for many healthcare providers and current strategies aimed at reversing the underlying chronic disease are only partially successful in this regard. Thus, research aimed at identifying dyspnea-specific medications to complement existing therapies for the management of exertional symptoms is timely and clinically relevant. The purpose of this study is to test the hypothesis that single-dose inhalation of fentanyl citrate (a mu-opioid receptor antagonist) will improve the perception of dyspnea during strenuous exercise in healthy, young men in the presence of an external thoracic restriction. To this end, the investigators plan compare the effects of inhaled 0.9% saline placebo and inhaled fentanyl citrate (250 mcg) on detailed assessments of neural respiratory drive (diaphragm EMG), ventilation, breathing pattern, dynamic operating lung volumes, contractile respiratory muscle function, cardio-metabolic function and dyspnea (sensory intensity and affective responses) during symptom-limited, high-intensity, constant-work-rate cycle exercise testing with and without external thoracic restriction in healthy, men aged 20-40 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 14
- Male
- Aged 20-40 years
- FEV1 ≥80% predicted
- FEV1/FVC >70%
- Current or ex-smoker
- Body Mass Index <18.5 or >30 kg/m2
- History of cardiovascular, vascular, respiratory, renal, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction
- Taking doctor prescribed medications
- History of using pain-relieving (opioid) and/or anti-depressant medications in the previous 6 weeks
- Allergy to latex
- Allergy to lidocaine or its "caine" derivatives
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CWS+Fentanyl Citrate (250 mcg) Fentanyl Citrate Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of nebulized fentanyl citrate (250 mcg) CWS+Fentanyl Citrate (250 mcg) CWS Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of nebulized fentanyl citrate (250 mcg) CWS+0.9% saline placebo CWS Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of 0.9% saline placebo CWS+0.9% saline placebo Placebo Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of 0.9% saline placebo No CWS+0.9% saline placebo Placebo No chest wall strapping (unloaded control) + single-dose inhalation of 0.9% saline placebo No CWS+Fentanyl Citrate (250 mcg) Fentanyl Citrate No chest wall strapping (unloaded control) + single-dose inhalation of nebulized fentanyl citrate (250 mcg)
- Primary Outcome Measures
Name Time Method Sensory intensity (Borg 0-10 scale) ratings of dyspnea at isotime Participants will be followed until all study visits are completed, an expected average of 3 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Montreal Chest Institute; McGill University Health Center & McGill University
🇨🇦Montreal, Quebec, Canada