NCT01412632已完成4 期
Deep Sedation in Spontaneously Breathing Patients Combined With Local Anesthesia Versus General Anesthesia in Gynecological Patients at Same Day Surgical at Hospitalsenheden Horsens
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
- 153
- 试验地点
- 1
- 主要终点
- pain on a NRS-scale from 0 to 10
研究概览
简要总结
The primary endpoint is to investigate the difference in pain between patients who receive deep sedation with spontaneous breathing versus patients who receive general anesthesia.
详细描述
Investigate the difference between two types of anesthesia.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •>18 years
- •are having a TCRE, TCRF or TCRP
- •speak and understand Danish
- •no mental problems
排除标准
- •<18 years old
- •don´t speak or understand Danish
- •mental problems
- •Lung problems
- •Big fibroma: >3x3 cm
- •Allergy towards i Propofol, Remifentanil and/or Citanest
研究组 & 干预措施
General vs deep sedation
Experimental
General anesthesia: remifentanil and propofol Deep sedation: remifentanil, propofol and citanest
干预措施: Remifentanil, propofol and citanest (Drug)
结局指标
主要结局
pain on a NRS-scale from 0 to 10
时间窗: up to 14 days
Measuring postoperative pain in TCRE, TCRF or TCRP patients
次要结局
- Medicin(1 day)
- PONV(postoperative and 2 weeks after discharge)
- Time(1 day)
- After discharge outcome measures(2 weeks)
研究者
研究点 (1)
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