Randomized Study of Preoperative Dexamethasone for Quality of Recovery in VATS Lung Resection Patients (APV)
研究概览
详细说明
This is a study composed by 2 groups of 50 patients undergoing VATS for lung cancer. All subjets will receive intraoperative intercostal nerve block with a maximum dose of 2 mg/kg of bupivacaine with epinephrine 1:200.000 at the beginning and at the end of procedure.
The control group will receive a bolus dose of dexamethasone (0.1 mg/kg) and the placebo group saline solution. The study drug or placebo will be administered at the time of anesthetic induction (approximately 30 minutes before surgical incision). Patients will be evaluated daily with the quality of recovery questionary, visual analogue pain and portable spirometry. And, the patients will have pulmonary lung function assessed by portable spirometry.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Québec、加拿大、G1v 4G5
- Institut Universitaire de Cardiologie et de Pneumologie de Québec, IUCPQ
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Québec、加拿大、G1V3H8
- IUCPQ
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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:
- resectable stage I and II lung cancer patients submitted to VATS
- american society of anesthesiology Classification (ASA) I or II
Exclusion Criteria:
- chronic pain;
- chronic analgesic consumption;
- severe renal or liver disease;
- endocrine or mental diseases;
- poorly controlled diabetes;
- allergy to bupivacaine;
- previous thoracotomy;
- systemic use of corticosteroids;
- morbid obesity;
- poor French comprehension precluding completion of the QoR-40 questionnaire;
- patient refusal.
学习计划
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 |
|---|---|
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安慰剂比较：Group 1
saline solution IV, bolus
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有源比较器：Group 2
0,1mg/kg systemic dose of dexamethasone, bolus
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It will be administered at the induction of the anesthesia
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 |
大体时间 |
|---|---|
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The primary outcome of this study will be postoperative quality of recovery measured by postoperative quality of recovery score 40 (QoR-40) global score.
大体时间：During the hospital stay and 1 year later
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During the hospital stay and 1 year later
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Time of analgesia between the final intercostal nerve block and the first patient-controlled analgesia (PCA) request;
大体时间：During the hospital stay and 1 year later
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During the hospital stay and 1 year later
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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Correlation between pain with visual analog scale and lung function through spirometry test with forced expiratory volume at one second (FEV1) and diffusion capacity (DLCO)
大体时间：During the hospital stay and 1 year later
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During the hospital stay and 1 year later
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Total opioid dose consumption in each group
大体时间：During the hospital stay and 1 year later
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During the hospital stay and 1 year later
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Side-effect of dexamethasone in the stress response to surgery
大体时间：During the hospital stay and 1 year later
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During the hospital stay and 1 year later
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合作者和调查者
调查人员
- 首席研究员：Paula A. Ugalde, Medicin、Institut Universitaire de Cardilogie et Pneumologie de Québec, IUCPQ
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
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
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.