A Study to Investigate of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle
Part of paid clinical trials in Rochester, Minnesota.
- Sponsor
- Mayo Clinic
- Study ID
- NCT05856136
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Respiratory Complication
- Respiratory Function Loss
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Fentanyl Injection — DRUGThree different fentanyl doses (used for sedation) will be evaluated on their effects on shear wave elastography (SWE) and breathing
Study Details
The purpose of this study is to evaluate opioid dose effects on the ability of the diaphragm muscle to generate higher force behaviors.
Key Dates
- Start date
- Jun 19, 2023
- Status verified
- Feb 2026
- Primary completion
- Dec 8, 2025
- Completion
- Jun 1, 2026
Study Design
- Enrollment
- 69 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Ultrasound Shear Wave Elastography Examination - LowerSubjects identified as being administered low dose opioids during an elective lower extremity orthopedic surgery per standard of care will undergo an ultrasound shear wave elastography examination while performing different breathing techniques.
- Experimental: Ultrasound Shear Wave Elastography Examination - MidSubjects identified as being administered mid dose opioids during an elective lower extremity orthopedic surgery per standard of care will undergo an ultrasound shear wave elastography examination while performing different breathing techniques.
- Experimental: Ultrasound Shear Wave Elastography Examination - HigherSubjects identified as being administered higher dose opioids during an elective lower extremity orthopedic surgery per standard of care will undergo an ultrasound shear wave elastography examination while performing different breathing techniques.
Primary Outcome Measure
Change in Young's modulus (derived from shear wave speed) [ Time Frame: Baseline, 10 min post-opioid ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 |
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