REMIFENTANIL AND LOCAL ANESTHESIA COMPARED WITH LOCAL ANESTHESIA FOR THE INSERTION OF CENTRAL VENOUS CATHETERS IN AWAKE PATIENTS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Maximal pain score on numeric rating scale (NRS) will be assessed after the insertion
研究概览
简要总结
At present, there is no reference protocol for Central Venous Catheter (CVC) insertion assuring analgesia, anxiolysis and safety. Medical teams use various levels of analgesia and anesthesia to realize this gesture, from single local anesthesia to general anesthesia. Remifentanil has been shown to decrease pain scores for insertion and removal of long-term central venous access. Remifentanil is also often employed for pediatric or labor analgesia for short acts as procedural sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •more than 18 years old
- •eligible for CVC insertion
排除标准
- •pregnancy
- •patients who can't give their consent
- •contra-indications to remifentanil infusion
研究组 & 干预措施
Remifentanil
Patients who undergone a Central Venous Catheter (CVC) insertion under remifentanil infusion
干预措施: Remifentanil (Drug)
Placebo
Patients who undergone a Central Venous Catheter (CVC) insertion under placebo infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Maximal pain score on numeric rating scale (NRS) will be assessed after the insertion
时间窗: up to 60 minutes
次要结局
- Evaluation of patient's anxiety by the Face Anxiety Scale(up to 60 minutes)
- Patient and physician's satisfaction by a 10-points numeric rating scale(up to 60 minutes)
- Number of adverse events(up to 60 minutes)
- Number of realized punctions(up to 60 minutes)