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 — DRUG
    Three 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 - Lower
    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.
  • Experimental: Ultrasound Shear Wave Elastography Examination - Mid
    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.
  • Experimental: Ultrasound Shear Wave Elastography Examination - Higher
    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.

Primary Outcome Measure

Change in Young's modulus (derived from shear wave speed) [ Time Frame: Baseline, 10 min post-opioid ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic MinnesotaRochesterMinnesota55905
Beth Martin
866-265-9263
Brenda Anderson
866-265-9263

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