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临床试验/NCT02125994
NCT02125994Unknown不适用

Comparison of the Effect of Ropivacaine 0.5% vs 0.375% on the Autonomous Nervous System During Shoulder Surgery in Beach Chair Position

Larissa University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Blood pressure fluctuations

研究概览

简要总结

It is established that the local anesthetic that is administered during an interscalene block affects the autonomic outflow to the heart. This is very well seen during shoulder surgery when the patient is positioned in beach chair pasition.

The investigators want to study the different effect of the two concentrations (0.5% and 0.375%) of ropivacaine on the autonomic nervous system through blood pressure and heart rate measurements.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

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

入选标准

  • Elective shoulder surgery
  • Age 18- 80 years old
  • ASA I - IV
  • Beach chair position

排除标准

  • Coagulopathy disorders
  • Infection at the puncture site for the interscalene block
  • Neurological deficit on the side to be operated
  • Allergy to local anesthetics
  • Psychiatric disorders
  • Patient's refusal
  • Problems with patient communication
  • Failure of the interscalene block

结局指标

主要结局

Blood pressure fluctuations

时间窗: Completion of the surgery

次要结局

  • Heart rate fluctuations(Completion of surgery)

研究者

发起方
Larissa University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marina Simaioforidou

Anesthesiologist

Larissa University Hospital

研究点 (1)

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