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NCT05856136 Clinical Trial

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

Respiratory Complication Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05856136
Other study ID # 20-007084
Secondary ID R21DA055848
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 19, 2023
Est. completion date April 2024

Study information
Verified date August 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate opioid dose effects on the ability of the diaphragm muscle to generate higher force behaviors.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in shear wave speed Measured by the ultrasound elastography of the diaphragm muscle reported in m/sec Baseline, 1 hour
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