Effects of Dexmedetomidine During Radiofrequency Ablation of Abdominal Tumours
Effects of Dexmedetomidine on Periprocedural Pain During Radiofrequency Ablation of Liver and Kidney Tumours
研究概览
详细说明
Although radiofrequency ablation (RF) is accepted as the best therapeutic choice for patients with early stage hepatocellular carcinoma when liver transplantation or surgical resection are not suitable options, it is still performed only in a few hospitals and experience is so far limited (Goldberg & Ahmed, 2002; Shiina et al., 2005). In addition, RF ablation is emerging as a viable alternative to surgery for inoperable patients with limited hepatic metastatic disease, especially from colorectal cancer. Although radiofrequency ablation has been accepted as a safe and effective treatment for liver and kidney tumours, there are few studies addressing periprocedural pain.
Thus, the optimal anaesthetic procedure is still to be determined. Currently at our institution RF is performed as monitored sedation procedure using remifentanil infusion supplemented with midazolam boluses, when considered necessary. However, when using remifentanil and midazolam combination it is quite difficult to avoid too deep respiratory depression.
Dexmedetomidine is an α2-adrenoreceptor agonist with sedative, analgesic and anxiolytic effects, and it has more selective α2-adrenergic effect than clonidine. Dexmedetomidine has a great deal of potential in this arena given its analgesic and anxiolytic properties while preserving respiratory drive (Bergese SD et al., 2010).
All patients will receive dexmedetomidine 0.4 µg/kg/hr infusion from the start of procedure. The infusion will be continued during the whole RF procedure.
At the same time all patients will receive remifentanil infusion according to TCI (target controlled infusion) protocol. Plasma concentration target will be set from 0.5 ng/ml and, if necessary, will be increased to achieve a comfortable state of patient (Ramsey Sedation Scale: 2-3).
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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Uppsala、瑞典、75185
- Uppsala 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
有资格学习的性别
描述
Inclusion Criteria:
- liver or/and kidney cancer for which radiofrequency ablation procedure is planned
- signed informed consent form
Exclusion Criteria:
- patient refusal
- pregnancy
- known allergy to dexmedetomidine or remifentanil
- atrioventricular block grade II or III or other significant cardiac conduction disturbance
- stroke
- low blood pressure not responding to treatment
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 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:右美托咪定
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Dexmedetomidine 0.4 µg/kg/hr infusion during RF procedure
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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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Patient Satisfaction With Sedation Technique
大体时间:After completion of procedure (within 15 minutes)
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Rating of how satisfied the patient was with their sedation on a scale of 1-5 with 1 being very dissatisfied and 5 being extremely satisfied
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After completion of procedure (within 15 minutes)
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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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Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate
大体时间:During procedure and up to 2 hours stay at the post-anesthesia care unit
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During procedure and up to 2 hours stay at the post-anesthesia care unit
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Ramsey Sedation Scale Score
大体时间:During the procedure and up to 2 hours stay at the post-anesthesia care unit
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Rating of depth of sedation.
Scale 1 - 6, 1 being wide awake and 6 being non-responsive
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During the procedure and up to 2 hours stay at the post-anesthesia care unit
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Maximal pain intensity
大体时间:During procedure and up to 2 hours stay at the post-anesthesia care unit
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The 11-point Numerical Rating Scale (NRS) to assess periprocedural pain.
Scale of 0-10, with 0:no pain and 10: pain as bad as it could be
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During procedure and up to 2 hours stay at the post-anesthesia care unit
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合作者和调查者
调查人员
- 首席研究员:Egidijus Semenas, MD, PhD、Uppsala University Hospital, Uppsala, Sweden
- 首席研究员:Mats Eriksson, MD, PhD、Uppsala University Hospital, Uppsala, Sweden
研究记录日期
研究主要日期
学习开始
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 (估计)
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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