围手术期吸入氢气对术后疼痛和炎症细胞因子的影响
研究概览
详细说明
氢气是一种无味、无色的气体,存在于自然环境中。 传统上认为它是生物惰性气体,这意味着它不参与生物过程。 然而,最近的研究表明,摄入氢气对皮肤鳞状细胞癌和寄生虫性肝炎具有治疗作用。 摄入氢气还可以通过去除活性氧 (ROS) 来减轻中风后的缺血再灌注损伤。 多项研究还表明,摄入氢气具有抗炎作用,可减少术后认知障碍、脑死亡小鼠的肺移植损伤和急性肺损伤。
摄入氢气的方式包括口服、吸入或静脉注射。 通过简易面罩、鼻导管或呼吸机吸入是最方便的方式。 事实证明,低浓度氢气吸入(1%-4%)是有效和安全的,不会对血流动力学、呼吸甚至动脉血气分析数据造成不良影响。 高浓度氢气吸入被证明是无害的,常用于潜水、治疗减压病和预防动静脉血栓栓塞。
目前的数据表明,背根神经节中的小胶质细胞在外部损伤后通过 Toll 样受体反应 (TLR) 被危险相关分子模式 (DAMP) 激活。 脂多糖 (LPS) 被认为是 TLR-4 受体激动剂,数据显示 LPS 与显着的神经炎症和慢性疼痛过程有关。 外周血单核细胞 (PBSC) 可能具有亲(例如 肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)、干扰素-γ(INF-γ) )及抗炎(如 LPS刺激后释放IL-4、IL-5、IL-9、IL-10)细胞因子。
目前的数据表明,摄入富氢水可以减少动物模型的炎症和疼痛评分。 吸入氢气与促炎细胞因子(如 IL-1β、IL-6、TNF-α 和 INF-γ)的减少有关。 此外,吸入氢气可减轻高位脊髓损伤大鼠的疼痛。
除了观察组间疼痛评分的差异外,我们还可以观察接受或未接受氢气吸入的患者在 LPS 刺激后 PBSC 中促炎和抗炎细胞因子的差异。 这可以告诉我们炎症过程是否通过吸入氢气在细胞水平上受到抑制。 据我们所知,目前还没有人体临床试验讨论氢气吸入对慢性疼痛的影响。 我们希望了解吸入氢气对术后疼痛评分和炎症的实际影响。 可以在此结果的基础上进行更大规模的随机临床试验。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New Taipei City、台湾、24300
- Fu Jen Catholic University Hospital
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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
描述
纳入标准:
- 椎间盘突出导致严重神经性疼痛且保守治疗难以治愈的患者,接受内窥镜椎间盘切除术。
排除标准:
- 美国麻醉师协会IV级或以上
- 心、肺、肾、肝严重受损及自身免疫性疾病
- 20岁以下或75岁以上
- 病人拒绝
- 围手术期发生严重并发症
- 目前怀孕
- 血红蛋白低于 10g/dL。
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:氢气吸入组
分配给该组的患者在整个过程中接受氢气吸入(4% 氢气通过鼻插管)和其他正常的术中护理。
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围手术期经鼻插管吸入 4% 氢气
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无干预:传统护理组
分配给该组的患者接受传统的术中护理。
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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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Post-operative pain
大体时间:12 hours after operation compared to pre-operative pain score measured in NRS
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Post-operative pain, measured in Numeric Rating Scale (NRS)
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12 hours after operation compared to pre-operative pain score measured in NRS
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Post-operative pain
大体时间:24 hours after operation compared to pre-operative pain score measured in NRS
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Post-operative pain, measured in Numeric Rating Scale (NRS)
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24 hours after operation compared to pre-operative pain score measured in NRS
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Post-operative pain
大体时间:1 month after operation compared to pre-operative pain score measured in NRS
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Post-operative pain, measured in Numeric Rating Scale (NRS)
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1 month after operation compared to pre-operative pain score measured in NRS
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Postoperative Pain
大体时间:1 hour after operation compared to pre-operative pain score measured in NRS
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1 hour after operation compared to pre-operative pain score measured in NRS
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1 hour after operation compared to pre-operative pain score measured in NRS
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Postoperative Pain
大体时间:At Postoperative Care Unit (PACU) immediately after surgery was completed, compared to preoperative pain, measured in NRS
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Postoperative pain, measured in Numeric Rating Scale (NRS)
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At Postoperative Care Unit (PACU) immediately after surgery was completed, compared to preoperative pain, measured in NRS
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Postoperative Pain
大体时间:6 hours after operation compared to pre-operative pain score measured in NRS
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Post-operative pain, measured in Numeric Rating Scale (NRS)
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6 hours after operation compared to pre-operative pain score measured in NRS
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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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炎症标记,白介素10
大体时间:与术前相比,立即服装
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白介素10
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与术前相比,立即服装
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炎症标记,肿瘤坏死因子-Alpha
大体时间:与术前相比,立即服装
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肿瘤坏死因子-Alpha
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与术前相比,立即服装
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炎症标记,白介素-1 beta
大体时间:与术前相比,立即服装
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Interleukin-1 beta
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与术前相比,立即服装
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Inflammation marker, Interferon-gamma
大体时间:immediate post-operation compared to pre-operation
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Interferon-gamma
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immediate post-operation compared to pre-operation
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合作者和调查者
出版物和有用的链接
一般刊物
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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 (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
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