Respiratory Function LossLungs and breathingDrugPhase 4
What this study is
The purpose of this study is to evaluate opioid dose effects on the ability of the diaphragm muscle to generate higher force behaviors.
What's being tested
- Fentanyl Injection
Intervention · DRUG
Three different fentanyl doses (used for sedation) will be evaluated on their effects on shear wave elastography (SWE) and breathing
Study details
- Official title
- Investigation of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle to Generate Higher Force Behaviors
- Sponsor
- Mayo Clinic
- Conditions
- Respiratory Function Loss · Respiratory Complication
- Enrolling
- 69 people
- Starts
- 2023-06-19
- Est. completion
- 2027-01-01
- Design
- Triple-blind, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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).
You can't join if
- Patients who refuse research participation.
- Patients who are pregnant.
- Patients with known pulmonary pathology (COPD, asthma requiring routine treatment).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMayo Clinic Minnesota
Rochester, Minnesota, United States
- Beth Martin · Contact866-265-9263martin.elizabeth@mayo.edu
- Brenda Anderson · Contact866-265-9263anderson.brenda@mayo.edu
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID 20-007084
Principal investigator
Carlos Mantilla, MD, PhD
Mayo Clinic
Have questions? The record lists no central contact. Use Consider me and the site team can reach you, or find them through ClinicalTrials.gov ↗.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.