Dexmedetomidine on Post-operative Blood Pressure in Bain Arteriovenous Malformation Embolization
2017年3月6日 更新者：Nan Jiang
Effects of Dexmedetomidine on Post-operative Blood Pressure in Patients Undergoing Brain Arteriovenous Malformation Embolization
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization.
The patients were randomized allocated to either Dexmedetomidine group or Control group.
Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline.
Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score, Ramsay score, and adverse events were recorded.
研究概览
详细说明
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization.
The patients were randomized allocated to either Dexmedetomidine group or Control group according to a random number.
Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline.
Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score-15 items, Ramsay score, and adverse events were recorded.
研究类型
介入性
注册 (预期的)
30
阶段
- 不适用
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
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510080
- 招聘中
- the First Affiliated Hospital of Sun Yetsen University
-
接触：
- Yi Liu, Master
- 电话号码：+86 13632391455
- 邮箱：liuyisysu@126.com
-
接触：
- Nan Jiang, professor
- 电话号码：+86 20 28823350
- 邮箱：NJiang_sysu@126.com
-
-
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
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- patients undergoing brain arteriovenous malformation embolization in the fist affiliated hospital, Sun Yat-sen University, aged 18-65 years, available to chat with,and the tracheal tube was extubated after surgery immediately.
Exclusion Criteria:
- abuse anesthetic analgesics and sedative drugs, or allergic to Dexmedetomidine or other anesthetics, hypotension or bradycardia before surgery, severe pulmonary disease with saturation of pulse oximetry less than 90% before surgery, or patients refused to attend in this study.
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Dexmedetomidine
Dexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly.
|
1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation.
其他名称：
|
|
安慰剂比较：Control group
Normal Saline was administered intravenously when tracheal extubation,equal volume of normal saline was mixed with 100 ml normal saline and maintained 4 hours constantly.
|
equal volume of normal saline was administered intravenously constantly after tracheal extubation.
其他名称：
|
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 |
|---|---|---|
|
urapidil consumption
大体时间：the end of the 6th hour after tracheal extubation
|
urapidil consumption was recorded by nurses every hour
|
the end of the 6th hour after tracheal extubation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
urapidil consumption on POD1
大体时间：the total consumption of urapidil on post-operative day 1.
|
urapidil consumption was recorded by nurses every hour
|
the total consumption of urapidil on post-operative day 1.
|
|
urapidil consumption on POD2
大体时间：the total consumption of urapidil on post-operative day 2.
|
urapidil consumption was recorded by nurses every hour
|
the total consumption of urapidil on post-operative day 2.
|
|
Visual Analogue score
大体时间：the end of the 6th hour after tracheal extubation
|
visual analogue score was measured by visual analogue scale
|
the end of the 6th hour after tracheal extubation
|
|
Visual Analogue score at 24th hour
大体时间：the end of the 24th hour after tracheal extubation
|
visual analogue score was measured by visual analogue scale
|
the end of the 24th hour after tracheal extubation
|
|
Visual Analogue score at 48th hour
大体时间：the end of the 48th hour after tracheal extubation
|
visual analogue score was measured by visual analogue scale
|
the end of the 48th hour after tracheal extubation
|
|
Quality of Recovery Score
大体时间：the end of the 6th hour after tracheal extubation
|
Quality of Recovery Score was measured by a 15-item quality of recovery scale
|
the end of the 6th hour after tracheal extubation
|
|
Quality of Recovery Score at 24th hour
大体时间：the end of the 24th hour after tracheal extubation
|
Quality of Recovery Score was measured by a 15-item quality of recovery scale
|
the end of the 24th hour after tracheal extubation
|
|
Quality of Recovery Score at 48th hour
大体时间：the end of the 48th hour after tracheal extubation
|
Quality of Recovery Score was measured by a 15-item quality of recovery scale
|
the end of the 48th hour after tracheal extubation
|
|
Analgesics consumption
大体时间：the end of the 6th hour after tracheal extubation
|
Analgesics consumption was recorded by nurse every hour
|
the end of the 6th hour after tracheal extubation
|
|
Analgesics consumption on POD1
大体时间：the total consumption of urapidil on post-operative day 1.
|
Analgesics consumption was recorded by nurse every hour
|
the total consumption of urapidil on post-operative day 1.
|
|
Analgesics consumption on POD2
大体时间：the total consumption of urapidil on post-operative day 2.
|
Analgesics consumption was recorded by nurse every hour
|
the total consumption of urapidil on post-operative day 2.
|
|
Bradycardia
大体时间：the end of the 6th hour after tracheal extubation
|
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
|
the end of the 6th hour after tracheal extubation
|
|
Bradycardia at 24th hour
大体时间：the end of the 24th hour after tracheal extubation
|
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
|
the end of the 24th hour after tracheal extubation
|
|
Bradycardia at 48th hour
大体时间：the end of the 48th hour after tracheal extubation
|
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
|
the end of the 48th hour after tracheal extubation
|
|
PONV
大体时间：the end of the 6th hour after tracheal extubation
|
post-operative nausea and vomiting (PONV) was recorded by nurse
|
the end of the 6th hour after tracheal extubation
|
|
PONV at 24th hour
大体时间：the end of the 24th hour after tracheal extubation
|
post-operative nausea and vomiting (PONV) was recorded by nurse
|
the end of the 24th hour after tracheal extubation
|
|
PONV at 48th hour
大体时间：the end of the 48th hour after tracheal extubation
|
post-operative nausea and vomiting (PONV) was recorded by nurse
|
the end of the 48th hour after tracheal extubation
|
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
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 (实际的)
2016年1月1日
初级完成 (预期的)
2017年12月31日
研究完成 (预期的)
2017年12月31日
研究注册日期
首次提交
2017年3月6日
首先提交符合 QC 标准的
2017年3月6日
首次发布 (实际的)
2017年3月9日
研究记录更新
最后更新发布 (实际的)
2017年3月9日
上次提交的符合 QC 标准的更新
2017年3月6日
最后验证
2017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
- NJiang2016-001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
the IPD will not be shared with others, since following investigations based on this trial is about to start.
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
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.