A Study to Investigate of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fentanyl Injection.
- Who it may be relevant to
- Registry conditions: Respiratory Function Loss, Respiratory Complication. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigation of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle to Generate Higher Force Behaviors
Overview
The purpose of this study is to evaluate opioid dose effects on the ability of the diaphragm muscle to generate higher force behaviors.
Interventions
- Drug Fentanyl Injection
Three different fentanyl doses (used for sedation) will be evaluated on their effects on shear wave elastography (SWE) and breathing
Primary outcome measures
- Change in Young's modulus (derived from shear wave speed) [Time frame: Baseline, 10 min post-opioid]
Eligibility criteria
Inclusion criteria
\- 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).
Exclusion criteria
- Patients who refuse research participation.
- Patients who are pregnant.
- Patients with known pulmonary pathology (COPD, asthma requiring routine treatment).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Mayo Clinic Minnesota — Rochester
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. PMID 42414111
Identifiers
NCT: NCT05856136 · 20-007084 · R21DA055848