Comparison of Dexmedetomidine and Meperidine for the Prevention of Shivering Following Coronary Artery Bypass Graft
Comparison of Dexmedetomidine and Meperidine for the Prevention of Shivering Following Coronary Artery Bypass Graft: Study Protocol of a Randomized Controlled Trial
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Cuicui Cao
- 电话号码：+8615863187590
- 邮箱：cccbzyxy@163.com
学习地点
-
-
Shandong
-
Jinan、Shandong、中国、250014
- 招聘中
- China, Shandong Qianfoshan Hospital
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首席研究员：
- Changping Gu
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
(1) aged between 18 and 75 years, (2) undergoing elective CABG, (3) ASA grade of II-IV, and (4) in accordance with ethical guidelines, patients must voluntarily participate in the trial and sign the informed consent for the clinical study.
Exclusion Criteria:
(1) patients with neurological or psychiatric disorders, (2) hepatic and renal dysfunction, (3) severe hyperthyroidism or hypothyroidism, (4) a body temperature greater than 38 °C or less than 36 °C, (5) postoperative hemodynamic instability, (6) preoperative use of a left ventricular assistance device, (7) pa severe diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, diabetic nephropathy), (8) participation in other clinical studies within the past 3 months, (9) acute or chronic pain, (10) addiction to opioids, (11) drug abuse, (12) pain management, and (13) neuromuscular disease, (14) on-pump CABG.
学习计划
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：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：控制组
|
Equal volume of normal saline to dexmedetomidine and meperidine group.
|
|
实验性的：右美托咪定组
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Dexmedetomidine would be intravenously infused at a dose of 1μg/kg over 15 minutes 30 min before the end of surgery
|
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有源比较器：Meperidine group
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Meperidine would be intravenously injected at a dose of 0.5mg/kg 30 min before the end of surgery
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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 incidence of postoperative shivering
大体时间：Within postoperative 24 hours
|
The incidence and severity of postoperative shivering and the rescue treatment
|
Within postoperative 24 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Times of postoperative rescue drugs used
大体时间：Within postoperative 24 hours
|
Within postoperative 24 hours
|
|
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The incidence of postoperative hypotension and bradycardia
大体时间：From the administration of experimental drugs to postoperative 24 hours
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From the administration of experimental drugs to postoperative 24 hours
|
|
|
Ramsay sedation score
大体时间：Within postoperative 3 days
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The minimum and maximum score are 1 and 6, respectively.
Score 1 represents that patients is anxious and agitated or restless , or both.
And score 6 represents that patients exhibits no response.
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Within postoperative 3 days
|
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Postoperative extubation time
大体时间：The time of extubation
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The time of extubation
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|
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Length of stay in the ICU
大体时间：The length of stay in ICU within postoperative 30 days
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The length of stay in ICU within postoperative 30 days
|
|
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The incidence of postoperative delirium
大体时间：Within postoperative 7 days
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Within postoperative 7 days
|
|
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The incidence of postoperative arrhythmias
大体时间：Within postoperative 24 hours
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Within postoperative 24 hours
|
|
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The incidence and severity of postoperative PONV
大体时间：Within postoperative 3 days
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Within postoperative 3 days
|
|
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Length of stay
大体时间：The first day after surgery to discharge
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The first day after surgery to discharge
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|
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The rate of all-cause death of participants
大体时间：Within postoperative 30 days
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Within postoperative 30 days
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- DMCABG
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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