Effects of Dexmedetomidine on OI, RI and Inflammatory Factors in Patients Undergoing Palatopalatyngoplasty.
2018年8月1日 更新者：General Hospital of Ningxia Medical University
Effects of Dexmedetomidine on Oxygenation Index, Respiratory Index and Inflammatory Factors in Patients Undergoing Palatopalatyngoplasty
The purpose of this study is to investigate the efficacy of dexmedetomidine on oxygenation index, respiratory index and inflammatory factors, and to explore the protective effect of the dexmedetomidine on respiratory function in patients undergoing palatopalatyngoplasty.
研究概览
详细说明
Obstructive sleep apnea syndrome is common among people, especially among obese people, Which is characterized by periodic or complete upper airway obstruction and hypoxia during sleep.
Intermittent hypoxia contributes to the lung damage by increased oxidative stress, inflammation.
Some researchers suggested that dexmedetomidine can inhibit inflammatory reaction and lessen the damage of respiratory function.
The aim of this study is to investigate the efficacy of dexmedetomidine on oxygenation index, respiratory index and inflammatory factors, and to explore the protective effect of the dexmedetomidine on respiratory function in patients undergoing palatopalatyngoplasty.
研究类型
介入性
注册 (预期的)
80
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
-
-
Ningxia
-
Yinchuan、Ningxia、中国、750004
- General Hospital of Ningxia Medical University
-
-
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 palatopalatyngoplasty
- ASA physical status II-III
- Aged 18-65 years
- BMI 18.5-30kg/m2
Exclusion Criteria:
- Bradycardia
- Atrioventricular block
- Allergic to the drugs
- Complicating pulmonary disease(including pulmonary infection,COPD, asthma and so on)
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：其他
- 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：Group D
40 patients receive a loading infusion of dexmedetomidine (1ug/kg)for 20min follow by a maintenance infusion (0.4ug/kg/h) continued until the end of the surgery
|
receive a loading infusion of dexmedetomidine (1ug/kg)for 20min follow by a maintenance infusion (0.4ug/kg/h) continued until the end of the surgery
|
|
安慰剂比较：Group C
40 patients receive matching placebo (normal saline)
|
receive matching placebo (equal volum of 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 |
|---|---|---|
|
The Oxygenation Index
大体时间：Intraoperative and immediately after surgery
|
Arterial blood samples were sampled before anaesthesia induction and immediately after surgery for the oxygenation index by using blood gas analyzer.
|
Intraoperative and immediately after surgery
|
|
The Respiratory Index
大体时间：Intraoperative and immediately after surgery
|
Arterial blood samples were sampled before anaesthesia induction and immediately after surgery for the respiratory index by using blood gas analyzer.
|
Intraoperative and immediately after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change of tumor necrosis factor-α before anesthesia and immediately after surgery
大体时间：Intraoperative and immediately after surgery
|
Blood samples were sampled before anaesthesia induction and immediately after surgery for the serum tumor necrosis factor-α，which were analyzed by using enzyme linked immunosorbent assay (ELISA).
|
Intraoperative and immediately after surgery
|
|
Change of interleukin-6 before anesthesia and immediately after surgery
大体时间：Intraoperative and immediately after surgery
|
Blood samples were sampled before anaesthesia induction and immediately after surgery for the serum interleukin-6, which were analyzed by using enzyme linked immunosorbent assay (ELISA).
|
Intraoperative and immediately after surgery
|
|
Change of interleukin-10 before anesthesia and immediately after surgery
大体时间：Intraoperative and immediately after surgery
|
Blood samples were sampled before anaesthesia induction and immediately after surgery for the serum interleukin-10, which were analyzed by using enzyme linked immunosorbent assay (ELISA).
|
Intraoperative and immediately after surgery
|
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。
调查人员
- 首席研究员：Li Na、General Hospital of Ningxia Medical University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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 (预期的)
2018年8月1日
初级完成 (预期的)
2019年4月30日
研究完成 (预期的)
2019年4月30日
研究注册日期
首次提交
2018年6月19日
首先提交符合 QC 标准的
2018年8月1日
首次发布 (实际的)
2018年8月2日
研究记录更新
最后更新发布 (实际的)
2018年8月2日
上次提交的符合 QC 标准的更新
2018年8月1日
最后验证
2018年8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
- MHX07
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
safety
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.