Neuroimaging Study of Dexmedetomidine-Induced Analgesia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Effect of Dexmedetomidine on Pain Processing Circuitry
研究概览
简要总结
Neuroimaging data will be collected for patients that are given low doses of dexmedetomidine in order to understand its analgesic effects.
详细描述
In this trial, participants will be given dexmedetomidine using a single-arm study design. fMRI will be conducted during this time. Cognitive assessments and pain monitoring will be administered at various points before and after dexmedetomidine is administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18 to 45
- •Normal body weight and habitus, BMI ≤ 30
- •Non-smoker
- •American Society of Anesthesiologists (ASA) physical status classification P1
- •Active health insurance coverage
- •Fully vaccinated against COVID-19
排除标准
- •Cardiovascular: myocardial infarction, coronary artery disease, peripheral vascular disease, arrhythmia, congestive heart failure, valvular disease, hypertension
- •Respiratory: bronchitis, chronic obstructive pulmonary disease, smoking, shortness of breath
- •Hepatic: hepatitis, jaundice, ascites
- •Neurologic: seizure, stroke, positive neurologic findings on neurologic examination, multiple sclerosis, Meniere's disease, Parkinson's disease, neuropathy, peripheral stenosis
- •Gastrointestinal: esophageal reflux, hiatal hernia, ulcer
- •Endocrine: diabetes, thyroid disease
- •Renal: acute or chronic severe renal insufficiency
- •Hematologic: blood dyscrasias, anemia, coagulopathies, on anticoagulant therapy
- •Musculoskeletal: prior surgery or trauma to head neck or face, arthritis, personal or family history of malignant hyperthermia
- •Psychiatric: history or treatment for an active psychiatric problem, depression
- •Reproductive: pregnancy, breast-feeding
- •Medications: regular use of prescription and non-prescription medications expected to affect CNS function, St. John's Wort
- •Allergies: dexmedetomidine, ondansetron, glycopyrrolate, phenylephrine
- •Dermatologic: ulcerative skin conditions or other dermatologic conditions which could interfere with blood pressure cuff placement.
- •MRI reasons for exclusion: History of head trauma, surgical aneurysm clips, cardiac pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlear implants, metal rods, plates, or screws, intrauterine device, hearing aid, dentures, metal injury to eyes, metallic tattoos anywhere on the body or near the eye.
研究组 & 干预措施
Dexmedetomidine
During the study visit, patients will be delivered dexmedetomidine anesthesia. 0.5mcg/kg of dexmedetomidine solution will be infused over 10 minutes, and then up to 0.5mcg/kg/hr will be maintained for an additional 20-30 minutes.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Effect of Dexmedetomidine on Pain Processing Circuitry
时间窗: Change in brain functional connectivity between baseline pain and dexmedetomidine pain during the fMRI visit, an average of 90 minutes
fMRI data will be used to compare changes in brain connectivity due to pain using functional network and seed-based correlation analyses when a pain cuff (Hokanson Rapid Cuff Inflator) is inflated during baseline and dexmedetomidine analgesia periods.
次要结局
未报告次要终点
研究者
Oluwaseun Johnson-Akeju, MD, MMSc
Associate Professor of Anaesthesia
Massachusetts General Hospital