DRKS00010109已完成2 期
Dexmedetomidine for saphenous nerve blockade!in patients undergoing anterior cruciate ligamentreplacement:A randomized, placebo-controlled,Triple'Blinded'Study - Dexmedetomidine for nervus saphenous block
KH Salzburg0 个研究点目标入组 40 人开始时间: 2016年3月2日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years(—)
- 性别
- All
入选标准
- •Study patients between 18 and 60 years
- •- ASA physical status 1-2
- •- BMI < 30 kg/m2
- •- Scheduled for posttraumatic ACLR
- •- Written informed consent given by study patients after being provided with detailed
- •information about the nature, risks, and scope of the clinical study as well as the
- •expected desirable and adverse effects of the drugs
- •- No legal incapacity and/or other circumstances rendering the study patients unable to
- •understand the nature, scope and possible consequences of the study
排除标准
- •-Anatomical abnormalities of the respective lower extremity identified by physical
- •examination or ultrasound
- •- Known allergy or hypersensitivity to ropivacaine or other amino-amide LA
- •-Known allergy or hypersensitivity to dexmedetomidine
- •- Participation in another clinical study within the last 4 weeks prior to study
- •- Coagulopathy
- •- Abnormalities in Blood pressure (Hypotension with a systolic BP < 90 mmHg and
- •hypertension with a systolic BP > 180 mmHg) during evaluation of eligibility for
- •study participation
- •- Coronary heart disease with an CCS III and higher
- •- Chronic heart failure NYHA III and higher
- •- Chronic opioid consumption exceeding a morphine-equivalent dose of 15mg per day
- •- Bradycardia with a heart rate after 5 min resting of < 40 b/min
- •- Abnormalities in ECG that are considered clinically relevant like AV-block 2nd degree
- •- Unreliability and/or lack of cooperation
- •- Other objections to participate in the study in the opinion of the investigator
研究者
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