Should Chronic Stimulant Medications be Continued Preoperatively in Patients With Attention Deficit Hyperactivity Disorder(ADHD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Heart Rate
研究概览
简要总结
Patients on chronic stimulant therapy for the treatment of Attention deficit hyperactivity disorder (ADHD) who are undergoing an outpatient surgical or diagnostic procedure will be randomized to one of two groups: stimulant medication administered on the day of surgery or stimulant medication withheld on the day of surgery. The choice of anesthetic pharmacology will be at the discretion of the attending anesthesiologist, but the endpoint will be a bispectral index (BIS) between 40 and 60 to ensure adequate and similar depth of anesthesia. Blood pressure, heart rate and use of vasopressors or anticholinergics will be recorded and the incidence of hypotension, bradycardia, or administration of medications will be compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be enrolled if they have been diagnosed with ADHD and have been taking amphetamines and/or methylphenidate for at least the last six months and are undergoing an outpatient surgical or diagnostic procedure.
排除标准
- •Patients will be excluded if they are taking antidepressant medications, anxiolytic medication, analgesia medications other than acetaminophen or NSAIDs, if they have an allergy to midazolam, or a have cardiac disease.
- •Procedures that entail the likelihood of blood transfusion will be excluded.
研究组 & 干预措施
Amphetamine and/or methylphenidate
Patients who took their amphetamine and/or methylphenidate the morning of surgery.
干预措施: Amphetamine and/or methylphenidate (Drug)
Hold stimulant medication
Patients who did not take their stimulant medication the morning of surgery.
干预措施: Hold stimulant medication (Other)
结局指标
主要结局
Heart Rate
时间窗: Day 1
Heart rate prior to anesthetic induction
次要结局
- Mean Blood Pressure(Day 1)
- Diastolic Blood Pressure(Day 1)
- Systolic Blood Pressure(Day 1)
- mYPAS Measurement in Patients Receiving Midazolam(Day 1)
- mYPAS Measurement in Patients Not Receiving Midazolam(Day 1)
研究者
Richard Cartabuke
Co-Director of Outpatient Anesthesia Services
Nationwide Children's Hospital