Respiratory Function LossPhase 4NCT05856136
A Study to Investigate the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle
A Phase 4 study testing Fentanyl Injection in people with Respiratory Function Loss and Respiratory Complication, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate opioid dose effects on the ability of the diaphragm muscle to generate higher force behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Function Loss, Respiratory Complication
- What is being tested?
- Fentanyl Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2023to 1 Jan 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female patients undergoing lower extremity orthopedic surgery at the study institutions (St. Mary Hospital and Rochester Methodist Hospital within the Mayo Clinic Rochester hospital system).
Who cannot join
- Patients who refuse research participation.
- Patients who are pregnant.
- Patients with known pulmonary pathology (COPD, asthma requiring routine treatment).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
Beth Martin, 866-265-9263, martin.elizabeth@mayo.edu
Brenda Anderson, 866-265-9263, anderson.brenda@mayo.edu
About this study
Official title: Investigation of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle to Generate Higher Force Behaviors
The purpose of this study is to evaluate opioid dose effects on the ability of the diaphragm muscle to generate higher force behaviors.
- Being tested
- Fentanyl Injection
- Keywords
- elastography, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl InjectionDrug
Three different fentanyl doses (used for sedation) will be evaluated on their effects on shear wave elastography (SWE) and breathing
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Shear Wave Elastography Examination - Lower | Experimental | Subjects 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. Receives: Drug: Fentanyl Injection |
| Ultrasound Shear Wave Elastography Examination - Mid | Experimental | Subjects 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. Receives: Drug: Fentanyl Injection |
| Ultrasound Shear Wave Elastography Examination - Higher | Experimental | Subjects 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. Receives: Drug: Fentanyl Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Young's modulus (derived from shear wave speed)
Measured by the ultrasound elastography of the diaphragm muscle reported in KPa
Measured: Baseline, 10 min post-opioid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start19 Jun 2023
- Primary completion8 Dec 2025
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Function LossStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Carlos B Mantilla, MD, PhD, Mayo Clinic
- Investigators
- Carlos Mantilla, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856136
- Sponsor's protocol ID
- 20-007084
- Other IDs
- R21DA055848
- Status last verified
- Jun 2026
- First submitted
- 4 May 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gransee HM, Urban MW, Martin BA, Stoltenberg AD, Knoll KM, Jahanian S, Anderson BK, Panchamia JK, Schroeder DR, Mantilla CB. Effects of fentanyl on diaphragm muscle force in patients undergoing knee arthroplasty: a randomised double-blind clinical trial. Br J Anaesth. 2026 Jul 7:S0007-0912(26)00418-6. doi: 10.1016/j.bja.2026.06.004. Online ahead of print.
PubMed 42414111