A Qualitative Comparison of Two Anesthetic Techniques in Children Undergoing Magnetic Resonance Imaging
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- The primary outcome variable will be the time spent in the MRI room
研究概览
简要总结
The goal of this study is to determine if there is a significant difference in the quality of care between the investigators' two standard anesthesia techniques for children undergoing a MRI of the body and/or extremity MRI. Quality of care will be measured by time spent in the MRI room as well as parental satisfaction, frequency of interruptions of the MRI scan, incidence-severity of respiratory complications, post anesthesia agitation, and time spent in the induction room, MRI room, and Post-Anesthesia Care Unit (PACU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects presenting as out-patients, scheduled to receive an anesthetic for MRI of body (spine, chest, abdomen, and/or pelvis) and/or extremity (arm and/or leg).
- •The subject must be a candidate for both anesthetic techniques. This decision will be made by a staff member of the Department of Anesthesiology. This staff member will not be a member of the study team and will obtain the consent for Anesthesia.
- •The subjects must be 12 months to 7 years (inclusive of the seventh year).
- •The subject's legally authorized representative has given written informed consent to participate in the study.
排除标准
- •The subject is residing in the Pediatric Intensive Care Unit, the Cardiac Intensive Care Unit, or Neonatal Intensive Care Unit.
- •Anxiolytic medication is ordered before the MRI (e.g., midazolam or ketamine).
- •The subject has a history or a family (parent or sibling) history of malignant hyperthermia.
- •The subject has life-threatening, medical conditions (American Society of Anesthesiologists Physical Status 4, 5 or 6).
- •The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is.
- •For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).
- •The subject is allergic to or has a contraindication to any of the drugs used in the study.
- •The subject has previously been treated under this protocol.
- •The subject has a tracheostomy or other mechanical airway device.
- •The subject has received within the past 12 hours an oral or intravenous alpha-adrenergic, beta-adrenergic agonist, or antagonist drugs (e.g., clonidine, propranolol, albuterol).
- •The subject is not scheduled to receive anesthesia-sedation care for the MRI.
- •The subject received one of the anesthetic regimens for the same MRI during the past six months.
研究组 & 干预措施
dexmedetomidine
Determine if there is a significant difference in the quality of care between our two standard anesthesia techniques for children undergoing a MRI of the body and/or extremity MRI.
干预措施: dexmedetomidine (Drug)
propofol
Determine if there is a significant difference in the quality of care between our two standard anesthesia techniques for children undergoing a MRI of the body and/or extremity MRI.
干预措施: propofol (Drug)
结局指标
主要结局
The primary outcome variable will be the time spent in the MRI room
时间窗: 2 years
次要结局
- Secondary outcome variables include incidence-severity of respiratory complications(2 years)