Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation
2018年3月6日 更新者：Peter Davis
Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children
To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus Injection of Dexmedetomidine.
研究概览
研究类型
介入性
注册 (实际的)
418
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、美国、15224
- Children's Hospital of Pittsburgh
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Pittsburgh、Pennsylvania、美国、15224
- Childrens Hospital of Pittsburgh
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
4年 至 10年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- children undergoing tonsillectomy with and without adenoidectomy and myringotomy and tube insertion
- ASA 1,2,3
- females who have started menses but have a negative urine pregnancy test
Exclusion Criteria:
- patients with known dysrhythmias,
- not recovering in the ICU
- developmental delay,
- autism communication disorder
- bleeding disorder
- PI discretion
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Dexmedetomidine
|
0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery
其他名称：
|
|
安慰剂比较：placebo
Normal saline
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Heart Rate (HR)
大体时间：Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
|
beats per minute (bpm)
|
Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
|
|
Systolic Blood Pressure (SBP)
大体时间：Systolic blood pressure (SBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. SBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
|
mmHg Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis. |
Systolic blood pressure (SBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. SBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
|
|
Diastolic Blood Pressure (DBP)
大体时间：Diastolic blood pressure (DBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. DBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
|
mmHg Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis. |
Diastolic blood pressure (DBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. DBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Emergence Agitation (EA)
大体时间：The highest PAED score for each patient within the first 30 minutes after waking up was recorded.
|
Using a Pediatric Anesthesia Emergence Delirium (PAED) score, emergence agitation scores will be recorded.
The PAED score consists of 5 different criteria which are assessed from 0 to 4 once the patient has woken up.
These criteria are then totaled; the total may range from 0 to 20, where 0 represents no emergence agitation and 20 represents maximal agitation.
For this study, patients with a maximum PAED score of >10 and >12 were considered to be agitated.
|
The highest PAED score for each patient within the first 30 minutes after waking up was recorded.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Peter J Davis, MD、University of Pittsburgh
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年1月1日
初级完成 (实际的)
2014年8月1日
研究完成 (实际的)
2014年8月1日
研究注册日期
首次提交
2012年2月6日
首先提交符合 QC 标准的
2012年2月7日
首次发布 (估计)
2012年2月8日
研究记录更新
最后更新发布 (实际的)
2018年3月8日
上次提交的符合 QC 标准的更新
2018年3月6日
最后验证
2018年3月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PRO11070498
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.