NCT02573987已完成4 期
MEOPA (Equimolar Mix of Oxygen and Nitrogen Monoxide) Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling.
Hospital St. Joseph, Marseille, France1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2013年3月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Analgesia efficiency
研究概览
简要总结
determine if efficiency of MEOPA anesthesia is at least equivalent to local anesthetics into the chorionic villus sampling in the first trimester of pregnancy
详细描述
Compare anxiety discomfort and side effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •18 and over
- •monofetal pregnancy
- •chorionic villus sampling medical indication without contra indication
- •informed consent signature
排除标准
- •pregnant under 18
- •multiple pregnancies
- •pregnancy inferior 11 aw
- •no informed consent signature
研究组 & 干预措施
Oxygen/nitrous oxide equimolar mix
Active Comparator
96 participants undergoing chorionic villi sampling. self administered inhalation of equimolar mixture of oxygen and nitrous oxide (MEOPA)
干预措施: Oxygen/nitrous oxide equimolar mix (Drug)
Lidocaine
Active Comparator
96 participants undergoing chorionic villi sampling infiltrative local anaesthesia of 1% lidocaine
干预措施: Lidocaine (Drug)
结局指标
主要结局
Analgesia efficiency
时间窗: 5 min after procedure
assessment of pain with visual analog scale
次要结局
- assessment of anxiety(5 min after biopsy)
研究者
Raoul Desbriere
Dr Desbriere
Hospital St. Joseph, Marseille, France
研究点 (1)
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