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NCT Number: NCT05856136

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

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

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Key information

Conditions

Respiratory Function Loss Respiratory Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Fentanyl Injection

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
May 12, 2023
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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