The Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron.
研究概览
简要总结
Perioperative anaphylaxis is a potentially life-threatening drug allergic reaction that can occur during anesthetic procedures. The purpose of this research is to determine the maximal nonirritating skin testing concentrations of midazolam, ketamine and ondansetron. These drugs are FDA approved and commonly used before, during and after surgical procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Not have a history of an adverse reactions to midazolam, ketamine or ondansetron
- •Ability to understand study procedures and to comply with them for the entire length of the study.
- •Contraception is not necessary, and we will include women of reproductive capability.
排除标准
- •Unstable patients.
- •History of any adverse reaction (allergy or sensitivity) to midazolam, ketamine or ondansetron.
- •Pregnant and Pediatric patients
- •Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
研究组 & 干预措施
Study Group
Study team is developing a new diagnostic skin testing procedure to determine non-irritant concentrations of midazolam, ketamine and ondansetron administered to patients before, during or after surgery.
干预措施: Skin Testing (Diagnostic Test)
结局指标
主要结局
Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron.
时间窗: 1 Day
Determine the maximal nonirritating concentrations of midazolam, ketamine and ondansetron
次要结局
- Skin Testing Results(1 Day)
研究者
Alexei Gonzalez-Estrada, MD
Alexei Gonzalez-Estrada, M.D.
Mayo Clinic