Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain (REFLECT)
2016年10月15日 更新者：Catherijne Knibbe、St. Antonius Hospital
A Randomised Clinical Trial Evaluating the Effect of Remifentanil vs Fentanyl During Cardiac Surgery on the Incidence of Chronic Thoracic Pain
This study will investigate the influence of intra-operative use of remifentanil versus fentanyl on the percentage of patients with chronic thoracic after cardiac surgery via sternotomy.
Secondary quantitative sensory testing is performed to determine thermal and electrical detection and pain threshold and the difference in pain variability scoring.
Postoperative pain scores, analgesic use, genetic variances and costs are measured.
研究概览
研究类型
介入性
注册 (实际的)
126
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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Nieuwegein、荷兰
- St. Antonius Hospital
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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
18年 至 85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 cardiac surgery via sternotomy (Coronary artery bypass graft (CABG) and/or valve replacement)
- Patients admitted to the ICU or PACU in the St. Antonius hospital
- Patients between 18 and 85 years old
- Patients weighing between 45 and 140 kg
- Written informed consent
Exclusion Criteria:
- Pregnancy/ breastfeeding
- Language barrier
- History of drug abuse
- Neurologic condition such as peripheral neuropathy
- Known remifentanil, fentanyl, morphine or paracetamol allergy
- Body Mass Index (BMI) > 35 kg/m2
- Prior cardiac surgery (re-operations);
- Patients with chronic pain conditions.
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：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Fentanyl
fentanyl bolus injections on an "as needed" base, next to the fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.
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fentanyl bolus injections on an "as needed" base, NEXT TO the fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.
其他名称：
fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.
其他名称：
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有源比较器：Remifentanil
remifentanil, starting with 0.15 ug/Ideal Body Weight(IBW)(kg)/min, next to fentanyl bolus injections (200-500 ug) on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.
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fentanyl bolus injections on an "as needed" base, NEXT TO the fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.
其他名称：
fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.
其他名称：
starting with 0.15 ug/IBW(kg)/min, next to fentanyl bolus injections (200-500 ug) on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.
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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Chronic thoracic pain
大体时间：1 year
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The percentage of patients reporting chronic thoracic pain one year after cardiac surgery.
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1 year
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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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Chronic thoracic pain
大体时间：3 and 6 months
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The percentage of patients reporting chronic thoracic pain three months and six months after cardiac surgery
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3 and 6 months
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Mean Numerical Rating Scale (NRS) score
大体时间：3, 6 and 12 months
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The mean NRS score of patients with chronic thoracic pain three months and six months after cardiac surgery.
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3, 6 and 12 months
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Quality of life
大体时间：3, 6 and 12 months
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The quality of life (QoL) three months, six months and one year after surgery.
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3, 6 and 12 months
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Thermal detection and pain thresholds
大体时间：preoperative, 3 days postoperative and 1 year after surgery
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The difference in postoperative pain thresholds three days and one year after cardiac surgery compared to the preoperative pain threshold (baseline)
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preoperative, 3 days postoperative and 1 year after surgery
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Pain variability
大体时间：preoperative, 3 days and 1 year postoperative
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Pain variability measured with a paradigm with electrical stimuli in only a part of the participants.
The difference in pain variability preoperative, three days postoperative and one year after cardiac surgery.
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preoperative, 3 days and 1 year postoperative
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Use of analgesics during and after hospitalization
大体时间：3 days during hospitalization and 3,6,12 months post surgery
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The required amounts of analgesics (morphine/paracetamol) during hospital stay; The use of analgesics three months, six months and one year after cardiac surgery, measured with questionnaires;
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3 days during hospitalization and 3,6,12 months post surgery
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Genetic variances
大体时间：Blood sample at time of surgery
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Genetic variances involved in pain sensitivity (e.g.
GTP-cyclohydrolase 1 (GCH-1), WDFY4, Zinc Finger gene Family (ZNF), Melanocortin 1 Receptor (MC1R)) and pharmacokinetics and pharmacodynamics of opiates (e.g.
glucuronosyl transferase (UGT), Multidrug Resistance-associated Protein (MRP), mu-opioid receptor gene 1 (OPRM1), Catechol-O-methyltransferase (COMT))
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Blood sample at time of surgery
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Total medical costs and productivity costs during one year, including costs of hospitalization days (ICU and non-ICU) and costs of medications
大体时间：1 year after surgery
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1 year after surgery
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Mean pain NRS (Numerical Rating Scale)
大体时间：3-5 days during hospitalization
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Mean NRS score during intensive care unit (ICU) stay and hospitalization.
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3-5 days during hospitalization
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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。
调查人员
- 首席研究员：CAJ Knibbe, Prof. Dr.、St. Antonius Hospital
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。
一般刊物
- de Hoogd S, Valkenburg AJ, van Dongen EPA, Daeter EJ, van Rosmalen J, Dahan A, Tibboel D, Knibbe CAJ. Short- and long-term impact of remifentanil on thermal detection and pain thresholds after cardiac surgery: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jan;36(1):32-39. doi: 10.1097/EJA.0000000000000887.
- de Hoogd S, Ahlers SJGM, van Dongen EPA, van de Garde EMW, Daeter EJ, Dahan A, Tibboel D, Knibbe CAJ. Randomized Controlled Trial on the Influence of Intraoperative Remifentanil versus Fentanyl on Acute and Chronic Pain after Cardiac Surgery. Pain Pract. 2018 Apr;18(4):443-451. doi: 10.1111/papr.12615. Epub 2017 Sep 28.
- de Hoogd S, Ahlers SJ, van Dongen EP, Tibboel D, Dahan A, Knibbe CA. Remifentanil versus fentanyl during cardiac surgery on the incidence of chronic thoracic pain (REFLECT): study protocol for a randomized controlled trial. Trials. 2014 Nov 27;15:466. doi: 10.1186/1745-6215-15-466.
有用的网址
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
2014年2月1日
初级完成 (实际的)
2016年4月1日
研究完成 (实际的)
2016年4月1日
研究注册日期
首次提交
2013年12月16日
首先提交符合 QC 标准的
2014年1月8日
首次发布 (估计)
2014年1月9日
研究记录更新
最后更新发布 (估计)
2016年10月18日
上次提交的符合 QC 标准的更新
2016年10月15日
最后验证
2016年10月1日
更多信息
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.