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临床试验/NCT01938755
NCT01938755已完成4 期

Hyperbaric Levobupivacaine for Spinal Anaesthesia

T.C. ORDU ÜNİVERSİTESİ1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2013年6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
73
试验地点
1
主要终点
degree of motor blockade

研究概览

简要总结

Spinal anaesthesia also called spinal block or sub-arachnoid block (SAB), is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space, generally through a fine needle.

There is no generic hyperbaric form of levobupivacaine currently available so we aimed in this study that to find the appropriate concentration of the levobupivacaine which achieves unilateral spinal anesthesia. The potential benefits of this type of anesthesia are less motor blockade and urinary retention, decrease in hospital stay. Therefore, it seems to be suitable for outpatient anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Approval to participate in the study and spinal anesthesia
  • American society of anesthesia (ASA) I,II physical status
  • Scheduled for lower extremity surgery

排除标准

  • Refuse to participate in the study
  • American society of anesthesia (ASA)III, IV physical status
  • Hypersensitivity to local anesthetics
  • Emergency surgery
  • Chronic pain treatment
  • Peripheral neuropathy
  • Severe systemic disease

研究组 & 干预措施

levobupivacaine I

Experimental

group that was administered levobupivacaine plus 60mg dextrose

干预措施: levobupivacaine (Drug)

levobupivacaine II

Experimental

group that was administered levobupivacaine plus 80 mg dextrose

干预措施: levobupivacaine (Drug)

levobupivacaine III

Experimental

group that was administered levobupivacaine plus 100 mg dextrose

干预措施: levobupivacaine (Drug)

结局指标

主要结局

degree of motor blockade

时间窗: until dissolve of motor blockade

次要结局

未报告次要终点

研究者

发起方
T.C. ORDU ÜNİVERSİTESİ
申办方类型
Other
责任方
Principal Investigator
主要研究者

özgür yağan

Özgür Yağan

T.C. ORDU ÜNİVERSİTESİ

研究点 (1)

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