Effect of Increasing Depth of Dexmedetomidine and Propofol Anesthesia on Upper Airway Morphology in Children With History of Obstructive Sleep Apnea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cross Sectional Area of the Pharyngeal Airway
研究概览
简要总结
The purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and propofol, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults with a history of obstructive sleep apnea (OSA) having an MRI scan.
The results of this study will help in making the best decisions regarding the anesthesia medications that are most appropriate for children, adolescents, and young adults with OSA during MRI studies.
详细描述
Patients with OSA are at risk for airway obstruction (a condition that makes it difficult to breath) during sedation and anesthesia. Dexmedetomidine and propofol are safe and effective drugs regularly used by anesthesiologists. These drugs are used to put patients to sleep for operations and certain studies like MRI scans. However, there have been no studies describing the effects these drugs have on the upper airway of children, adolescents, and young adults with OSA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with documented history of OSA by polysomnography who require anesthesia for MRI sleep study or MRI brain imaging study.
- •Subjects must be 12 months to 25 years of age (inclusive)
- •Either the subject (if subject's age is 18-25) or the subject's legally authorized representative has given written informed consent to participate in the study
排除标准
- •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 propofol or dexmedetomidine.
- •The subject has a tracheostomy or other mechanical airway device
- •The subject is not scheduled to receive anesthesia-sedation care for the MRI
- •The subject has a history or a family (parent or sibling) history of malignant hyperthermia.
研究组 & 干预措施
Propofol
干预措施: Propofol (Drug)
Dexmedetomidine
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Cross Sectional Area of the Pharyngeal Airway
时间窗: during MRI within first 10 minutes of scanning
The primary outcome measures will be the cross sectional area of the pharyngeal airway of the patients measured at two levels soft palate (nasopharyngeal) and base of the tongue (retroglossal). Magnetic resonance images of the airway were obtained during low (1 mcg/kg/hr) and high (3 mcg/kg/hr) doses of DEX or low (100 mcg/kg/m) and high (200 mcg/kg/m) doses of Propofol. All were administered through an intravenous (IV) catheter.
次要结局
- Obstructive Index Until Recovery Room Discharge(During MRI and until recovery room discharge - approximately 30-250 minutes)
- Room Air SpO2(During MRI and until recovery room discharge - approximately 30-250 minutes)
- Respiratory Disturbance Index(During MRI and until recovery room discharge - approximately 30-250 minutes)
- Needed Artificial Airway(During MRI and until recovery room discharge - approximately 30-250 minutes)