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临床试验/NCT01926561
NCT01926561已完成不适用

Predicting the Occurence of Hypotensive Bradycardic Events in the Patients Undergoing Arthroscopic Shoulder Surgery in the Sitting Position Under Interscalene Brachial Plexus Block

Daegu Catholic University Medical Center1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
1
主要终点
Patient's age and gender, fasting time, administered volume, blood pressure, and heart rate variability

研究概览

简要总结

Patients's demographics and perioperative factors affect the occurrence of hypotensive bradycardic events in the patients undergoing arthroscopic shoulder surgery in the sitting position under interscalene block.

详细描述

Patients' age, Side of the block,Horner's syndrome, the degree of blockade, preoperative fasting time and fluid administration volume, waiting time for sitting position after the block, intraoperative use of opioids and antihypertensives, and change of heart rate variability before the block and after sitting position affect the occurrence of hypotensive bradycardic events in the patients undergoing arthroscopic shoulder surgery in the sitting position under interscalene block.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 15 and 80 years
  • American Society of Anesthesiologists physical status I-II
  • Body mass index < 35 kg/m2

排除标准

  • Coagulation deficiencies
  • Known allergies to local anesthetics
  • Neurologic deficit on the side to be operated
  • Inflammation at the puncture site for interscalene brachial plexus block
  • Coronary artery disease
  • Cardiac conduction disorders and arrhythmias
  • Congestive heart disease
  • Diabetes mellitus
  • Serum electrolyte abnormalities
  • Autonomic dysfunction
  • Psychiatric disorders
  • Patients refusal
  • Communications difficulties
  • Failure of interscalene brachial plexus block

结局指标

主要结局

Patient's age and gender, fasting time, administered volume, blood pressure, and heart rate variability

时间窗: Prior to ISBPB

Patients'age and gender, preoperative fasting time and volume of fluid administered, pre-block mean arterial pressure and heart rate, logarithmically transformed low frequency, high frequency, and total power of heart rate variability

次要结局

  • Side of the block, volume of local anesthetics used, number of patients having Horner's syndrome, hoarseness, and subjective dyspnea, degree of dermatomal and motor blockade(20 minutes after the end of local anethetics injection)
  • Waiting time for sitting position, heart rate variability, mean arterial pressure, heart rate, frequency of antihypertensives and opioids use, and onset of hypotensive bradycardic events(after the sitting position (expected average of 2 hours including surgery readiness time and duration of surgery))

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

Department of Anesthesiology and Pain Medicine

Daegu Catholic University Medical Center

研究点 (1)

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