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临床试验/NCT02016391
NCT02016391已完成4 期

Effects of Dexmedetomidine on Periprocedural Pain During Radiofrequency Ablation of Liver and Kidney Tumours

Uppsala University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Patient Satisfaction With Sedation Technique

研究概览

简要总结

The purpose of he study is to evaluate effects of dexmedetomidine on pain during radiofrequency ablation of liver and kidney tumours.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • liver or/and kidney cancer for which radiofrequency ablation procedure is planned
  • signed informed consent form

排除标准

  • patient refusal
  • pregnancy
  • known allergy to dexmedetomidine or remifentanil
  • atrioventricular block grade II or III or other significant cardiac conduction disturbance
  • low blood pressure not responding to treatment

研究组 & 干预措施

Dexmedetomidine

Experimental

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Patient Satisfaction With Sedation Technique

时间窗: After completion of procedure (within 15 minutes)

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

次要结局

  • Ramsey Sedation Scale Score(During the procedure and up to 2 hours stay at the post-anesthesia care unit)
  • Maximal pain intensity(During procedure and up to 2 hours stay at the post-anesthesia care unit)
  • Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate(During procedure and up to 2 hours stay at the post-anesthesia care unit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Egidijus Semenas

Consultant in anaesthesia and intensive care

Uppsala University Hospital

研究点 (1)

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