Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain
2011年3月24日 更新者:First Affiliated Hospital, Sun Yat-Sen University
Effects of Parecoxib on Emergence Delirium and Postoperative Pain in Elderly Patients Undergoing Abdominal Surgery After General Anesthesia
This prospective, double blind, placebo-controlled, parallel group study will be conducted in three study centers in Guangzhou, China.
Patients aged older than 65 (ASA I-III) undergoing primary elective abdominal surgery with general anesthesia will be involved in this study.
According to previous studies and our pilot trial, the sample size was estimated to be 900 subjects (each center recruiting 300 patients).
All eligible patients will be randomly assigned to one of two groups: study group receiving parecoxib and control group receiving normal saline.
All patients will be managed with by a standard clinical anesthesia protocol with a sevoflurane-based general anesthesia with continuous intravenous remifentanil, followed by a postoperative PCA with morphine.
The emergence delirium will be evaluated by two persons blinding to medication and grouping using Riker sedation-agitation scale immediately since tracheal extubation and at specific time points until patients being discharged from PACU.
Pain intensity assessments and pain relief assessments will also be conducted by the patients at given time points in 2 days postoperatively.
The morphine-sparing effect, tolerability and safety of parecoxib will be investigated as well.
研究概览
详细说明
The inclusion criteria of this study includes:
- Aged older than 65;
- Primary elective abdominal surgery under general anesthesia;
- Ability to understand how to use pain assessment scales and PCA device.
The outcome measures of this study includes:
- Emergence Delirium Assessment;
- Pain intensity and pain relief efficacy endpoints;
- Tolerability and Safety Assessments
研究类型
介入性
注册 (预期的)
900
阶段
- 第四阶段
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
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Guangdong
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Guangzhou、Guangdong、中国、510080
- 招聘中
- The First Affiliated Hospital of Sun Yat-sen University
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接触:
- Haihua Shu, MD; Ph D
- 电话号码:8273 +86-20-87755766
- 邮箱:shuhaihua@gmail.com
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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
65年 至 90年 (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:
- Aged older than 65;
- Body weight of at least 50 kg;
- Primary elective abdominal surgery under general anesthesia;
- Preoperative health graded as class ASA I-III, based on medical history and physical examination;
- Ability to understand how to use pain assessment scales and PCA device
Exclusion Criteria:
- Emergency or revised abdominal surgery;
- History of known use of analgesics or any other agent that could interfere with analgesic responses during the up to 24 h before receipt of the study medication which including NSAIDs, tricyclic antidepressants, neuroleptic or antipsychotic agents, or corticosteroids (except routine preoperative medication);
- History of known or suspected drug abuse;
- Known allergy, sensitivity, or contraindication to opioid and non-opioid analgesic drugs;
- History of bleeding disorders, peptic ulceration, or anticoagulant use within the past month;
- History of asthma or bronchospasm;
- History of inflammatory bowel disease, a chronic or acute renal or hepatic disorder, coronary heart disease;
- History of dementia and psychological disorder;
- Contraindication to parecoxib.
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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:parecoxib
Parecoxib, a water-soluble prodrug of valdecoxib, is a high-selective COX-2 inhibitor that is first available for intravenous administration.
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The study group will receive first dose of intravenous (IV) injection of parecoxib sodium 40 mg (in a volume of 2 ml) 60 min before the anticipated end of surgery, followed 2 ml IV injection of parecoxib 40 mg will be occurred at 12, 24 and 36 h after the first dose of parecoxib.
其他名称:
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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 |
|---|---|---|
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emergence agitation
大体时间:45 min after anesthesia
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the incidence of emergence agitation after recovery from general anesthesia before discharging from PACU
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45 min after anesthesia
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The amount of morphine consumption and Pain intensity
大体时间:48h postoperatively
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The amount of morphine consumption from PCA pump at PACU, 12, 24, 36, and 48h after first dose of study medication; Pain intensity (NRS scores) at 2, 4, 6, 9, 12, 18, 24, 36 and 48 h after the first dose of study medication.
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48h postoperatively
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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。
合作者
调查人员
- 首席研究员:Haihua Shu, MD; Ph D、First Affiliated Hospital, Sun Yat-Sen 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
2010年9月1日
初级完成 (预期的)
2011年12月1日
研究完成 (预期的)
2012年6月1日
研究注册日期
首次提交
2010年10月12日
首先提交符合 QC 标准的
2010年10月13日
首次发布 (估计)
2010年10月14日
研究记录更新
最后更新发布 (估计)
2011年3月25日
上次提交的符合 QC 标准的更新
2011年3月24日
最后验证
2010年10月1日
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
- SHHparecoxib1
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