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临床试验/NCT03256786
NCT03256786已完成不适用

Effects of Preanesthetic Forced Air Warming and Administration of Warmed Intravascular Fluid on Preventing Hypothermia and Shivering During Cesarean Delivery Under Spinal Anesthesia

Hallym University Kangnam Sacred Heart Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年7月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
incidence of hypothermia and shivering

研究概览

简要总结

The majority of women (> 60%) developed hypothermia and shivering during cesarean delivery. Core hypothermia may be associated with a number of adverse outcomes in patients, including shivering, wound infection, coagulopathy, increased blood loss and transfusion requirements, decreased metabolism and prolonged recovery. Shivering can result in interference with monitoring, increased tension on wound edges, and increased oxygen consumption.

A previous study has shown several modalities to prevent hypothermia and shivering in patients undergoing cesarean delivery with spinal anesthesia. But, single modality intervention have shown marginal or no efficacy.

Neuraxial anesthesia reduces the threshold for vasoconstriction and shivering. It often also produces a lower body sympathectomy that provokes a core to peripheral redistribution of body heat. It is difficult to treat the core to peripheral redistribution of body heat. However redistribution can be prevented by preanesthetic cutaneous warming. Prewarming hardly changes core temperature that remains well regulated, but it markedly increases peripheral tissue heat content. As a result, prewarming reduces the core to peripheral tissue temperature gradient and the propensity for redistribution after the induction of anesthesia.

We therefore hypothesized that Combined modality active warming consisting of preoperative 15 min of surface warming using a forced air warmer before spinal anesthesia and coloading of warmed intravenous fluid might reduce perioperative hypothermia and shivering in women undergoing cesarean delivery. Additionally, We tested the hypothesis that maintaining maternal normothermia increases newborn temperature and Apgar scores.

研究设计

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

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients scheduled for cesarean delivery under spinal anesthesia
  • The American Society of Anesthesiologists physical status class one or two
  • female between 20 and 45

排除标准

  • Patients with heart disease
  • Patients with infectious disease
  • Patients with coagulopathy
  • Patients with a drug allergy
  • In case of switching to general anesthesia
  • Patients BMI under 18.5 or over 31

结局指标

主要结局

incidence of hypothermia and shivering

时间窗: immediately after arrival at the postanesthesia care unit

次要结局

  • temperature of newborn(immediately after delivery of newborn)

研究者

发起方
Hallym University Kangnam Sacred Heart Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Choi Eun MI

Clinical Professor

Hallym University Kangnam Sacred Heart Hospital

研究点 (1)

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