NCT03038958已完成4 期
Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy
Centre Hospitalier Universitaire Saint Pierre2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年4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
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Duration of sensory block
研究概览
简要总结
This study compares intrathecal 1% plain chloroprocaine with intrathecal 2% hyperbaric prilocaine for patients undergoing ambulatory knee arthroscopy in terms of efficacy 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
- Double (Participant, Outcomes Assessor)
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
- 否
入选标准
- •American Society of Anesthesiology physical status (ASA) ≤ III
- •Age 18-80 year
- •Height between 160 and 185 cm
- •Signed informed consent obtained prior to any study specific assessments and procedures
排除标准
- •Cardiac pathology (such as Heart failure, Aortic stenosis)
- •Coagulation disorders (INR>1.3, platelet < 80 000/mm3)
- •Known allergy to local anaesthetics
- •Disagreement of the patient
研究组 & 干预措施
Isobaric 2-chloroprocaine
Active Comparator
The 50 mg dose of isobaric 2-chloroprocaine will be administered to patients undergoing ambulatory knee arthroscopy
干预措施: Isobaric 2-chloroprocaine (Drug)
Hyperbaric prilocaine 2%
Active Comparator
The dose of 50 mg of Hyperbaric prilocaine 2% will be administered to patients undergoing ambulatory knee arthroscopy
干预措施: Hyperbaric prilocaine (Drug)
结局指标
主要结局
Duration of sensory block
时间窗: Until complete release of sensory block
Total duration of sensory block is the interval time between the end of intrathecal injection and the complete recovery of sensory block
次要结局
- Onset time of sensory block(up to 30 minutes)
- Duration of motor block(Until complete regression of motor block)
- Side-effects (hypotension, bradycardia, urinary retention)(up to 24 hours)
- Pain assessed by Visual Analog Scale(up to 24 hours)
- Onset time of motor block(up to 30 minutes)
研究者
研究点 (2)
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