ED50 and ED95 of Intranasal Dexmedetomidine in Pediatric Patients Undergoing Transthoracic Echocardiography Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- The ED95 doses for intranasal dexmedetomidine
研究概览
简要总结
The median effective dose (ED50) and ED95 of intranasal dexmedetomidine as a single bolus have not been described for sedation in children undergoing transthoracic echocardiography (TEE) study. This information is important to compare agents and to determine the most effective sedative dose. The investigators performed a two-stage study to determine the ED50 and the ED95 of intranasal dexmedetomidine to investigate age-related differences in participants undergoing transthoracic echocardiography study.
详细描述
The investigators performed a two-stage study to determine the ED50 and the ED95 of intranasal dexmedetomidine in children undergoing transthoracic echocardiography study. In phase 1, 120 participants were randomized in a Dixon-Massey study to describe the minimum local sedative dose. In phase 2, a further 160 participants were randomly allocated to receive sedation with doses in the upper dose-response range to define the ED95
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children, aged between one and 24 months. classified as (American Society of Anesthesiologists) ASA physical status I or II, undergoing TEE were enrolled in the study.
排除标准
- •Known allergy or hypersensitive reaction to dexmedetomidine
- •Organ dysfunction, and significant developmental delays or behavior problems
- •Cardiac arrhythmia
- •Known. acyanotic congenital heart disease or children after cardiac interventional procedures for follow-up examination.
研究组 & 干预措施
1-6 months (Group 1)
干预措施: intranasal dexmedetomidine (Drug)
7-12 months (Group 2)
干预措施: intranasal dexmedetomidine (Drug)
13-18 months (Group 3)
干预措施: intranasal dexmedetomidine (Drug)
19-24 months (Group 4)
干预措施: intranasal dexmedetomidine (Drug)
结局指标
主要结局
The ED95 doses for intranasal dexmedetomidine
时间窗: up to 0.5 hours after transthoracic echocardiography
Phase 2 was a dose-escalation study. After interim analysis of the phase 1 results, four dose levels above the calculated ED50 were defined. Dose spacing was set at 0.3 mcg/kg of intranasal dexmedetomidine consistent with the re-estimated standard deviation (SD). Defined levels were set at about 2.5, 2.75, 3.0, and 3.25 mcg/kg of intranasal dexmedetomidine. Criteria for success and failure were identical to those in phase 1. Successful sedation was defined as a MOAA/S score between 0-3 and allowed the acquisition of clinically adequate diagnostic-quality images, while failure was defined as a MOAA/S score \>3 within 45 minutes or clinically adequate diagnostic-quality images could not be acquired
The ED50 doses for intranasal dexmedetomidine
时间窗: up to 0.5 hours after transthoracic echocardiography
Phase 1: The starting dose of dexmedetomidine was 2.5 mcg/kg. These doses varied by 0.1 mcg/kg, according to the up-and-down method 18. If the detected MOAA/S score was \>3 within 45 minutes after intranasal administration, or clinically adequate diagnostic-quality images could not be acquired, sedation was considered a failure; and the dexmedetomidine dose was increased by 0.1 mcg/kg in the next patient of the same age group. In contrast, if the detected MOAA/S score was ≤3 and the acquisition of clinically adequate diagnostic-quality images was possible, the sedation was considered successful; and the dexmedetomidine dose was decreased by 0.1 mcg/kg in the next patient o
Score of physical movement
时间窗: up to 0.5 hours after transthoracic echocardiography
Movement score was recorded by sonographers who were blinded to the sedative regimen. 1. No movement 2. Occasional, slight movement 3. Frequent, slight movement 4. Vigorous movement limited to extremities 5. Vigorous movement, including torso and head
次要结局
- sedation induction time(up to 2 hours after drug administration)
- Wake -up time(up to 2 hours after drug administration)
研究者
Wenhua Zhang
Director, Clinical Resesearch
Guangzhou Women and Children's Medical Center