Study on Opioid Effects on Diaphragm Muscle

This study is looking into how different doses of Fentanyl Injection (an opioid used for sedation) affect your diaphragm muscle's ability to generate force. Researchers want to understand if opioids impact how well this important breathing muscle works. You may be able to join if you are an adult undergoing lower extremity orthopedic surgery at St. Mary Hospital or Rochester Methodist Hospital within the Mayo Clinic Rochester system. The study aims to understand what changes occur in the diaphragm's stiffness (measured by Young's modulus) after receiving Fentanyl. The current recruitment status is unclear, and the study plans to enroll 69 participants.

Study design
This interventional study plans to enroll 69 adult participants. It will evaluate three different doses of Fentanyl Injection.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your diaphragm's stiffness will be measured at the start of the study and again 10 minutes after receiving the opioid.

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NCT05856136

A Study to Investigate of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle

Recruiting
PHASE4Ages 18+InterventionalBasic science
Mayo Clinic
~69 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Fentanyl Injection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Young's modulus (derived from shear wave speed)
Measured over Baseline, 10 min post-opioid
Respiratory Function Loss
Respiratory Complication
1 sites across 1 states
Minnesota1
  • Carlos Mantilla, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Exclusion

Patients who refuse research participation.
Patients who are pregnant.
Patients with known pulmonary pathology (COPD, asthma requiring routine treatment).
  • Change in Young's modulus (derived from shear wave speed)Baseline, 10 min post-opioid

    Measured by the ultrasound elastography of the diaphragm muscle reported in KPa