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临床试验/NCT04027842
NCT04027842已完成不适用

Effect of 10 Minute-prewarming on Core Body Temperature During Gynecologic Laparoscopic Surgery Under General Anesthesia

Daegu Catholic University Medical Center2 个研究点 分布在 2 个国家目标入组 54 人开始时间: 2019年1月9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
54
试验地点
2
主要终点
the incidence of intraoperative hypothermia

研究概览

简要总结

Previous research has shown beneficial effects of prewarming on preventing inadvertent perioperative hypothermia (IPH). Warming the surface of the body before the induction of anesthesia can reduce the temperature difference between the core and periphery, thereby reducing the degree of core-to-peripheral thermal redistribution. It has been proved that initiation of warming before surgery can be more useful for preventing IPH than warming only during surgery. Nevertheless, there are not many researches on effects of short period (<30 min) prewarming, especially in gynecologic laparoscopic surgery. Accordingly, the investigators designed this study to test if IPH can be effectively prevented when 10 minutes of prewarming is added to intraoperative active warming in patients undergoing gynecologic laparoscopic surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA physical status 1 or 2 patients
  • patients who underwent gynecologic laparoscopic surgery under general anesthesia

排除标准

  • preexisting hypothermia (<36℃) or hyperthermia (>37.5℃)
  • anesthesia last for <1 hour or >2 hours
  • conversion from laparoscopic surgery to laparotomy
  • patients with a body mass index (BMI) ≥ 31kg/m2
  • patients with known thyroid disease

结局指标

主要结局

the incidence of intraoperative hypothermia

时间窗: on arrival at operating theater, before anesthesia induced, every 15 minutes after anesthetic induction until admission to the post anesthetic care unit (PACU)

Number of Participants whose core temperature was than 36℃ was recorded at each time point.

次要结局

  • the incidence of postoperative shivering(on the admission to PACU, 30 minutes after the admission to PACU)
  • Time-temperature interaction during the first 1 hour of anesthesia(Core body temperature was recorded at 15-min intervals from initiation of anesthesia for 1 hour.)

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

Jin Yong Jung

Professor of anesthesiology and pain medicine

Daegu Catholic University Medical Center

研究点 (2)

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