NCT02523144已完成4 期
A Qualitative Comparison of Oral Chloral Hydrate vs 2.0 or 3.0 mcg/kg Nasal Dexmedetomidine in Children Undergoing Transthoracic Echocardiography
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 279
- 试验地点
- 1
- 主要终点
- Time to sedation
研究概览
简要总结
Sedation Techniques for children undergoing transthoracic echocardiography (TTE).
详细描述
The goal in this study is to determine if there is a significant difference in the quality of sedation between two standard sedation techniques and between two doses of dexmedetomidine for children undergoing (TTE).
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
- Single (Participant)
入排标准
- 年龄范围
- 3 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients scheduled to receive sedation for transthoracic echocardiography
- •Subject must be a candidate for both types of anesthetic and both doses of dexmedetomidine
- •Must be 3 months to 36 months of age
排除标准
- •The subject has a history of cardiac conduction system disease (e.g. 1st or 2nd degree AV block) or channelopathy (e.g. long QT).
- •The subject is taking digoxin, alpha-adrenergic or beta-adrenergic agonist or antagonist (e.g., clonidine, propranolol, albuterol), anti-arrhythmic medications, or vasodilators (e.g. ACE inhibitors)
- •The subject has received a dose of any other sedative within 48 hours.
- •The subject has life-threatening, medical conditions (American Society of Anesthesiologists Physical Status 4, 5). 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 severe coarctation of the aorta (risk of exaggerated vasoconstriction)
- •The subject has Moyamoya disease (risk of recurrent stroke)
研究组 & 干预措施
Chloral Hydrate + placebo
Active Comparator
Oral chloral hydrate sedation in flavored syrup plus nasal saline placebo
干预措施: Chloral Hydrate (Drug)
Chloral Hydrate + placebo
Active Comparator
Oral chloral hydrate sedation in flavored syrup plus nasal saline placebo
干预措施: Placebo (Drug)
Dexmedetomidine 2mcg/kg + placebo
Active Comparator
Nasal dexmedetomidine sedation 2 mcg/kg plus oral flavored syrup placebo
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 2mcg/kg + placebo
Active Comparator
Nasal dexmedetomidine sedation 2 mcg/kg plus oral flavored syrup placebo
干预措施: Placebo (Drug)
Dexmedetomidine 3mcg/kg + placebo
Active Comparator
Nasal dexmedetomidine sedation 3 mcg/kg plus oral flavored syrup placebo
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 3mcg/kg + placebo
Active Comparator
Nasal dexmedetomidine sedation 3 mcg/kg plus oral flavored syrup placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to sedation
时间窗: 30 minutes
Achieve Ramsay sedation \>3 within 30 minutes of administration of drug
次要结局
- The number of sonographer pauses(Participants will be followed for the duration of the procedure, average of 1 hour)
- Need for rescue dexmedetomidine(Participants will be followed for the duration of the procedure, average of 1 hour)
- Duration of sedation level >3(Patients will be followed for the duration of the procedure, average of 1 hour)
- Incidence of respiratory complications(Participants will be followed for the duration of the hospital stay, average of 2 hours)
- Vital sign deviations of more than 30% from baseline(Participants will be followed for the duration of the hospital stay, average of 2 hours)
- Post anesthesia drowsiness(Participants will be followed for the duration of the post procedure stay, average of 1 hour)
- Duration of Post Anesthesia Care Unit phase(Participants will be followed for the duration of the post procedure stay, average of 1 hour)
- Time to oral fluid intake(Participants will be followed for the duration of the post procedure stay, average of 1 hour)
- Time to discharge(Participants will be followed for the duration of the post procedure stay, average of 1 hour)
- Satisfaction of parents(Up to 3 days)
- Severity of respiratory complications(Participants will be followed for the duration of the hospital stay, average of 2 hours)
- Post anesthesia agitation(Participants will be followed for the duration of the post procedure stay, average of 1 hour)
研究者
研究点 (1)
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