Sedation and Pain (The Effect of IV Sedation on Pain Perception)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Pain Rating Change
研究概览
简要总结
The investigators propose to evaluate the potential effect of sedation on pain perception in two ways, by asking for a participant's pain rating(subjective) and by evaluating a subject's brain activation using fMRI(objective).
详细描述
We propose to contrast and compare the effect of propofol and midazolam, two GABA-related sedative drugs, and dexmedetomidine, an alpha-2 adrenergic agonist, on pain perception in human volunteers by asking a participant to rate their pain and by evaluating a subject's brain activation using fMRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •19 years or older able to follow study instructions
排除标准
- •Age less than 19 or greater than 40
- •Pregnant female
- •Obesity (BMI > or =35)
- •Non-English speaking/reading participants
- •Sleep apnea
- •Pulmonary problems such as moderate or severe bronchial asthma
- •Cardiovascular problems such as hypertension
- •History of claustrophobia
- •Presence of a pacemaker, defibrillator, surgically placed metallic object (e.g., hip replacement)or other implanted device
- •Presence of an unremoved bullet or shrapnel in the body
- •Presence of a prosthetic that is not removable
- •Presence of a hearing aid needed for hearing
- •Head girth exceeding that of the head coil used in the magnet
- •Extensive metalwork on or in teeth, or irremovable false teeth or bridgework
- •Chronic analgesic medication
- •Excessive tattoos (due to local skin heating with tattoos containing ferromagnetic particles)
- •History of surgery for which details are unavailable
- •Allery due to study drugs
- •History of drug abuse
研究组 & 干预措施
Propofol
Administration via an IV
干预措施: propofol (Drug)
Midazolam
Administration via an IV
干预措施: midazolam (Drug)
Dexmedetomidine
Administration via an IV
干预措施: dexmedetomidine (Drug)
结局指标
主要结局
Pain Rating Change
时间窗: Sedation
Mechanical Slide Algometer (www.decisionaidsonline.com), Range: "No Pain Sensation" (1) to " Most Intense Sensation Imaginable" (10) 10 point scale. Change Time Points: Baseline (no sedation), Sedation. Same Day Intervention.
次要结局
未报告次要终点
研究者
Michael Froelich
M.D.
University of Alabama at Birmingham