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Opioid Analgesic

Opioid Exposure for Respiratory Complications

Phase 4
Recruiting
Led By Carlos Mantilla, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 hour
Awards & highlights

Study Summary

This trial tests how opioids affect the strength of the diaphragm muscle, which helps with breathing.

Who is the study for?
This trial is for adult men and women who are having lower limb orthopedic surgery at St. Mary Hospital or Rochester Methodist within the Mayo Clinic in Rochester. It's not for those with lung conditions like COPD or asthma, anyone who doesn't want to participate in research, or pregnant individuals.Check my eligibility
What is being tested?
The study is looking into how different doses of an opioid called Fentanyl affect the diaphragm muscle's ability to work harder and generate force during breathing, especially after surgery.See study design
What are the potential side effects?
While not explicitly listed, common side effects of Fentanyl can include drowsiness, nausea, confusion, constipation, sedation, respiratory depression (slowed breathing), and potential dependency.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 hour
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 hour for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in shear wave speed

Side effects data

From 2009 Phase 4 trial • 237 Patients • NCT01795898
100%
Aneurysm ruptured
54%
Dizziness
39%
Nausea
26%
Vomiting
16%
Somnolence
5%
Pruritus
2%
Headache
2%
Insomnia
1%
Weakness
1%
Palpitation
1%
Rashes
1%
Chest pain
1%
Cold clammy perspiration
1%
Flushing
1%
Muscle trembling
1%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fentanyl

Trial Design

3Treatment groups
Experimental Treatment
Group I: Ultrasound Shear Wave Elastography Examination - MidExperimental Treatment1 Intervention
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.
Group II: Ultrasound Shear Wave Elastography Examination - LowerExperimental Treatment1 Intervention
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.
Group III: Ultrasound Shear Wave Elastography Examination - HigherExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,242 Previous Clinical Trials
3,773,549 Total Patients Enrolled
4 Trials studying Respiratory Failure
14,180 Patients Enrolled for Respiratory Failure
National Institute on Drug Abuse (NIDA)NIH
2,488 Previous Clinical Trials
2,622,451 Total Patients Enrolled
Carlos Mantilla, MD, PhDPrincipal InvestigatorMayo Clinic

Media Library

Respiratory Failure Clinical Trial 2023: Fentanyl Injection Highlights & Side Effects. Trial Name: NCT05856136 — Phase 4
~104 spots leftby Jun 2025
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