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临床试验/NCT03439007
NCT03439007已完成不适用

Prediction of Hypotension During Induction of Anesthesia in Pediatric Patients Using Dynamic Variables of Fluid Responsiveness

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2018年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
Pleth variability index

研究概览

简要总结

The purpose of this study is to find out which of the variables related to fluid responsiveness (e. g., perfusion index [PI], pleth variability index [PVI], pulse oximetry plethysmographic variance [ΔPOP]) can best predict hypotension during induction of anesthesia.

详细描述

Propofol is a widely used intravenous agent for induction of anesthesia in children aged 3 years and more. A well-known adverse effect of propofol is hypotension, which can be properly dealt with hydration and/or administration of inotropics and vasopressors. However, severe hypotension during anesthetic induction may not be immediately cured if anesthesiologist should concentrate on ventilation of the patient. Since pediatric patients have smaller reservoir for oxygen supply and perfusion to various organs of the body, delayed handling of severe hypotension may result in irreversible damage to the vital organs.

Hypotension during anesthesia is caused, though not entirely, by dehydration. There are a variety of non-invasive variables that are related to the severity of dehydration, but which of the variables can best predict anesthesia-induced hypotension in pediatric patients. In this study, we will measure the preoperative values of non-invasive variables related to fluid status, and find out which of them are most closely related to the occurrence of hypotension during anesthesia induction.

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
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 3-6 years
  • Scheduled to undergo elective surgery under general anesthesia

排除标准

  • American Society of Anesthesiologists (ASA) physical status classification III or more
  • Contraindication of laryngeal mask airway (LMA) insertion:
  • (1) Esophagitis, gastritis, peptic ulcer, pyloric or intestinal stenosis, history of upper gastrointestinal tract surgery, body mass index [BMI] > 30, expected anesthesia time > 2 hours)
  • Arrhythmia
  • Left ventricular failure (ejection fraction < 40%)
  • Congenital syndromes which are known to affect cardiopulmonary function
  • Use of inotropics/vasopressors before anesthesia
  • History of allergic reaction to drugs used in general anesthesia

结局指标

主要结局

Pleth variability index

时间窗: changes for 10 minutes

pleth variability index

次要结局

  • Adverse event_1(10 minutes)
  • Adverse event_2(10 minutes)
  • Adverse event_3(10 minutes)
  • Adverse event_4(10 minutes)
  • Heart rate(changes for 10 minutes)
  • perfusion index(changes for 10 minutes)
  • pulse oximetry plethysmograpic variance(changes for 10 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hee-Soo Kim

Prof.

Seoul National University Hospital

研究点 (1)

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