NCT05856136 A Study to Investigate of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle
| NCT ID | NCT05856136 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mayo Clinic |
| Condition | Respiratory Function Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 69 participants |
| Start Date | 2023-06-19 |
| Primary Completion | 2025-12-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 69 participants in total. It began in 2023-06-19 with a primary completion date of 2025-12-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Carlos Mantilla, MD, PhD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT05856136 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Respiratory Function Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05856136 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05856136 currently recruiting?
Yes, NCT05856136 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mayo Clinic to inquire about joining.
Where is the NCT05856136 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05856136 clinical trial?
NCT05856136 is sponsored by Mayo Clinic. The principal investigator is Carlos Mantilla, MD, PhD at Mayo Clinic. The trial plans to enroll 69 participants.