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临床试验/DRKS00010109
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

发起方
KH Salzburg

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