Investigation of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle to Generate Higher Force Behaviors
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Change in shear wave speed
研究概览
简要总结
The purpose of this study is to evaluate opioid dose effects on the ability of the diaphragm muscle to generate higher force behaviors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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).
排除标准
- •Patients who refuse research participation.
- •Patients who are pregnant.
- •Patients with known pulmonary pathology (COPD, asthma requiring routine treatment).
研究组 & 干预措施
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.
干预措施: Fentanyl Injection (Drug)
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.
干预措施: Fentanyl Injection (Drug)
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.
干预措施: Fentanyl Injection (Drug)
结局指标
主要结局
Change in shear wave speed
时间窗: Baseline, 1 hour
Measured by the ultrasound elastography of the diaphragm muscle reported in m/sec
次要结局
未报告次要终点
研究者
Carlos B Mantilla, MD, PhD
Principal Investigator
Mayo Clinic