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临床试验/NCT03514342
NCT03514342已完成不适用

The Effects of Difference in Pupil Size Between Bilateral Eyes on Cardiac Sympathetic Nervous Activity Following Interscalene Brachial Plexus Block

Daegu Catholic University Medical Center1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2018年6月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Post-sitting sympathetic nervous activity

研究概览

简要总结

This study evaluates the effects of Horner's syndrome on cardiac autonomic nervous activity after interscalene brachial plexus block. Cardiac autonomic nervous activity and bilateral pupil diameters will be measured in a scotopic light condition, 30 minutes after interscalene brachial plexus block under ultrasound guidance and 15 minutes after the subsequent sitting position.

详细描述

Stellate ganglia provide sympathetic fibers to the heart. Ipsilateral stellate ganglion block accompanied by interscalene brachial plexus block causes Horner's syndrome presenting with miosis, ptosis, and anhidrosis. The extent of Horner's syndrome can be represented by the difference in pupil diameter between bilateral eyes. Cardiac autonomic nervous activity affected by stellate ganglion block can be measured by calculation of heart rate variability parameters.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status 1
  • Arthroscopic shoulder surgery under interscalene brachial plexus block

排除标准

  • Coagulopathy
  • Infection at the site of brachial plexus block
  • Peripheral neuropathy or neurologic sequelae on the operative limb
  • Allergy to local anesthetics or history of allergic shock
  • Psychiatric diseases
  • Patient refusal
  • Difficulty communicating with medical personnel
  • Arrhythmias
  • Ischemic heart disease
  • Hypertension
  • Diabetes mellitus
  • Thyroid dysfunction
  • Conduction abnormalities on electrocardiogram
  • Electrolyte imbalance
  • Medications affecting cardiac conduction
  • Contralateral vocal cord palsy
  • Contralateral hemidiaphragmatic paresis or paralysis
  • Contralateral pneumothorax or hemothorax

研究组 & 干预措施

Interscalene brachial plexus block

Ultrasound-guided interscalene brachial plexus block with 25 ml to 30 ml of 0.75% ropivacaine

干预措施: 0.75% ropivacaine (Drug)

Interscalene brachial plexus block

Ultrasound-guided interscalene brachial plexus block with 25 ml to 30 ml of 0.75% ropivacaine

干预措施: Interscalene brachial plexus block (Procedure)

结局指标

主要结局

Post-sitting sympathetic nervous activity

时间窗: 15 minutes after the sitting position following interscalene brachial plexus block

Natural-log transformed low frequency power of heart rate variability calculated using R wave to R wave intervals obtained for 5 minutes between 10 and 15 minutes after the sitting position following interscalene brachial plexus block

次要结局

  • Pre-anesthetic sympathovagal balance(15 minutes after baseline acclimiation)
  • Pre-anesthetic overall variability of autonomic nervous system(15 minutes after baseline acclimation)
  • Post-sitting ipsilateral pupil diameter(15 minutes after the sitting position following interscalene brachial plexus block)
  • Post-sitting contralateral pupil diameter(15 minutes after the sitting position following interscalene brachial plexus block)
  • Post-anesthetic ipsilateral pupil diameter(30 minutes after interscalene brachial plexus block)
  • Post-anesthetic contralateral pupil diameter(30 minutes after interscalene brachial plexus block)
  • Pre-anesthetic ipsilateral pupil diameter(15 minutes after baseline acclimation)
  • Pre-anesthetic contralateral pupil diameter(15 minutes after baseline acclimation)
  • Post-sitting parasympathetic nervous activity(15 minutes after the sitting position following interscalene brachial plexus block)
  • Post-sitting sympathovagal balance(15 minutes after the sitting position following interscalene brachial plexus block)
  • Post-sitting overall variability of autonomic nervous system(15 minutes after the sitting position following interscalene brachial plexus block)
  • Post-anesthetic sympathetic nervous activity(Between 25 and 30 minutes after interscalene brachial plexus block)
  • Post-anesthetic parasympathetic nervous activity(Between 25 and 30 minutes after interscalene brachial plexus block)
  • Post-anesthetic sympathovagal balance(Between 25 and 30 minutes after interscalene brachial plexus block)
  • Post-anesthetic overall variability of autonomic nervous system(Between 25 and 30 minutes after interscalene brachial plexus block)
  • Pre-anesthetic sympathetic nervous activity(15 minutes after baseline acclimiation)
  • Pre-anesthetic parasympathetic nervous activity(15 minutes after baseline acclimiation)
  • Sensory blockade(30 minutes after interscalene brachial plexus block)
  • Motor blockade(30 minutes after interscalene brachial plexus block)

研究者

发起方
Daegu Catholic University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

JongHae Kim

Associate Professor

Daegu Catholic University Medical Center

研究点 (1)

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