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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle to Generate Higher Force Behaviors
- ClinicalTrials.gov ID
- NCT05856136
- Acronym / sponsor ID
- 20-007084
- Keywords
- elastography, ultrasound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate opioid dose effects on the ability of the diaphragm muscle to generate higher force behaviors.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Shear Wave Elastography Examination - Lower | Experimental | Drug: Fentanyl InjectionSubjects 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. |
| Ultrasound Shear Wave Elastography Examination - Mid | Experimental | Drug: Fentanyl InjectionSubjects 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. |
| Ultrasound Shear Wave Elastography Examination - Higher | Experimental | Drug: Fentanyl InjectionSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (3 listed)
- Patients who refuse research participation.
- Patients who are pregnant.
- Patients with known pulmonary pathology (COPD, asthma requiring routine treatment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl InjectionThree different fentanyl doses (used for sedation) will be evaluated on their effects on shear wave elastography (SWE) and breathing | Drug | Ultrasound Shear Wave Elastography Examination - Higher, Ultrasound Shear Wave Elastography Examination - Lower, Ultrasound Shear Wave Elastography Examination - Mid |
Primary outcome
Change in Young's modulus (derived from shear wave speed)
Time frame: Baseline, 10 min post-opioid
Measured by the ultrasound elastography of the diaphragm muscle reported in KPa
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 42414111Gransee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos Mantilla, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Young's modulus (derived from shear wave speed) (time frame: Baseline, 10 min post-opioid). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05856136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.