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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

Adult male and female patients undergoing lower extremity orthopedic surgery at St. Mary Hospital and Rochester Methodist Hospital within the Mayo Clinic Rochester hospital system

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult having leg surgery at St. Mary or Rochester Methodist Hospital.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 hour

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

Pruritus

Insomnia

Headache

Weakness

Palpitation

Rashes

Chest pain

Cold clammy perspiration

Flushing

Muscle trembling

Constipation

100%

80%

60%

40%

20%

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,584 Total Patients Enrolled

4 Trials studying Respiratory Failure

14,180 Patients Enrolled for Respiratory Failure

National Institute on Drug Abuse (NIDA)NIH

2,464 Previous Clinical Trials

2,618,393 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this research study still being accepted?

"Clinicaltrials.gov offers evidence that recruitment is still underway for this medical trial, which was first announced on May 1st 2023 and most recently updated on the 4th of same month."

Answered by AI

What risks are associated with Ultrasound Shear Wave Elastography Examination - Lower?

"Due to the status of Ultrasound Shear Wave Elastography Examination - Lower as an approved Phase 4 treatment, our team at Power has assigned it a safety rating of 3."

Answered by AI

What is the scope of recruitment for this clinical trial?

"Indeed, the clinicaltrials.gov website reflects that this medical trial is presently looking for participants; it was initially posted on May 1st 2023 and has been updated as recently as 4th of May 2023. The study necessitates 200 contributors from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Carlos B Mantilla, MD, PhD 2023. "A Study to Investigate of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05856136.