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临床试验/NCT02364219
NCT02364219Unknown不适用

Impact of Prewarming on Perioperative Body Core Temperature and the Outcomes of Cytoreductive- and Major Open Abdominal Surgery: A Randomised Trial (PREWARM)

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
48
试验地点
2
主要终点
body core temperature drop from induction of anesthesia to start of surgery

研究概览

简要总结

The primary purpose of this study is to determine whether a prewarming period of at least 30 minutes during induction of general and combined epidural anesthesia reduces the core temperature drop normally occuring in patients undergoing cyto-reductive and major abdominal surgery. In addition the effect of prewarming on intra and postoperative body core temperature will be evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • age > 18
  • elective cytoreductive or major abdominal surgery caused by ovarian cancer, primarily or secondary

排除标准

  • age < 18
  • refusal participate in study
  • pregnant or breast-feeding women
  • cardiac ejection fraction < 30%
  • terminal renal insufficiency requiring dialysis
  • severe pulmonary disease (Gina-Classification< 3)
  • neurological and/or psychiatric disease
  • patient is placed in an institution due to court order
  • lack of language skills/understanding
  • employee of Charité Berlin
  • alcohol addiction
  • refusal of epidural anesthesia or failure to insert epidural catheter
  • participation in other perioperative, invasive studies which prohibit further study inclusion

结局指标

主要结局

body core temperature drop from induction of anesthesia to start of surgery

时间窗: approximately 30-40 minutes

次要结局

  • body core temperature at the end of surgery(duration of surgery)

研究者

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

Michael Sander

Univ.-Prof. M. Sander

Charite University, Berlin, Germany

研究点 (2)

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