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

Investigation of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle to Generate Higher Force Behaviors

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05856136
Enrollment
69
Registered
2023-05-12
Start date
2023-06-19
Completion date
2026-06-01
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Function Loss, Respiratory Complication

Keywords

elastography, ultrasound

Brief summary

The purpose of this study is to evaluate opioid dose effects on the ability of the diaphragm muscle to generate higher force behaviors.

Interventions

Three different fentanyl doses (used for sedation) will be evaluated on their effects on shear wave elastography (SWE) and breathing

Sponsors

Mayo Clinic
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in Young's modulus (derived from shear wave speed)Baseline, 10 min post-opioidMeasured by the ultrasound elastography of the diaphragm muscle reported in KPa

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCarlos Mantilla, MD, PhD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026