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

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05856136

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

28.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Function Loss Respiratory Complication	Drug: Fentanyl Injection	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ultrasound Shear Wave Elastography Examination - Lower 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.	Drug: Fentanyl Injection Three different fentanyl doses (used for sedation) will be evaluated on their effects on shear wave elastography (SWE) and breathing
Experimental: Ultrasound Shear Wave Elastography Examination - Mid 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.	Drug: Fentanyl Injection Three different fentanyl doses (used for sedation) will be evaluated on their effects on shear wave elastography (SWE) and breathing
Experimental: Ultrasound Shear Wave Elastography Examination - Higher 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.	Drug: Fentanyl Injection Three different fentanyl doses (used for sedation) will be evaluated on their effects on shear wave elastography (SWE) and breathing

Arm

Intervention/Treatment

Experimental: Ultrasound Shear Wave Elastography Examination - Lower

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.

Drug: Fentanyl Injection

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

Experimental: Ultrasound Shear Wave Elastography Examination - Mid

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.

Drug: Fentanyl Injection

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

Experimental: Ultrasound Shear Wave Elastography Examination - Higher

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.

Drug: Fentanyl Injection

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

Outcome Measures

Primary Outcome Measures

Change in shear wave speed [Baseline, 1 hour]
Measured by the ultrasound elastography of the diaphragm muscle reported in m/sec

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Minnesota	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic
National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Carlos Mantilla, MD, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Carlos B Mantilla, MD, PhD, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05856136

Other Study ID Numbers:

20-007084
R21DA055848

First Posted:

May 12, 2023

Last Update Posted:

May 12, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Carlos B Mantilla, MD, PhD, Principal Investigator, Mayo Clinic

elastography

ultrasound

Additional relevant MeSH terms:

Fentanyl

Study Results

No Results Posted as of May 12, 2023