NCT00763789Unknown不适用
Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department. A Randomized Clinical Trial.
Copenhagen University Hospital at Herlev2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2008年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- the total time spent in the operating room
研究概览
简要总结
The purpose of this study is to compare a new method: the combination of conscious sedation with remifentanil (a shortlasting opioid drug) and local anaesthesia, with the traditional general anaesthesia for hysteroscopic surgery. The primary outcomes are: the time spent in the operation room, the time to full mobilisation postoperatively and the time to complete recovery postoperatively and the time to discharge. Secondary outcome: patient satisfaction.
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
- 否
入选标准
- •Age > 18 years,
- •ASA classification I-II
- •Speaks and writes danish
- •Signed informed consent
排除标准
- •ASA classification III-VI
- •Emotional disorder - medically treated within a week before surgery
- •Patients in risk of perioperative aspiration - who must be intubated
- •BMI > 35
- •Patients who have been using pain medicine within a week before surgery (except PCM and NSAID)
- •Patients who have been using sleeping medicine or sedatives within a week before surgery
结局指标
主要结局
the total time spent in the operating room
次要结局
未报告次要终点
研究者
研究点 (2)
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