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临床试验/NCT04991272
NCT04991272已完成不适用

Effect of 10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature in Patients Undergoing Urologic Surgery Under General Anesthesia

Inje University1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2021年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
1
主要终点
incidence of hypothermia at the end of the operation

研究概览

简要总结

Hypothermia occurs frequently during general anesthesia. This study is to evaluate the efficacy of 10 minutes of prewarming and warmed fluid during urologic surgery.

详细描述

During general anesthesia, vasodilation distributes body heat and leads to hypothermia. Especially during urologic operation (transurethral resection of bladder and prostate), bladder irrigation worsens hypothermia. Hence, various methods are used to maintain core temperature during operation.

Previous studies have demonstrated that prewarming of the patient is effective in maintaining core temperature perioperatively. However, more than 50% of patients who have applied prewarming for more than 30 minutes preoperatively are reported to fall in hypothermia. Hence, developing simple and effective method to prevent hypothermia is expected.

Hence, the investigators planned to examine the effect of active warming (10 minutes of prewarming preoperatively and prewarmed intravenous fluid intraoperatively) on hypothermia in patients undergoing urologic operation under general anesthesia.

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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •patients undergoing urologic surgery(transurethral resection of bladder, prostate)

排除标准

  • •moderate to severe cardiopulmonary, renal impairment
  • •thyroid disease
  • •any infection sign
  • •abnormal temperature prior to induction of general anesthesia (<36'C or >37.5'C)
  • •refusal to participate in the study
  • •unable to understand the study

研究组 & 干预措施

warming group

Active Comparator

Warming group patients are applied prewarming with bair-hugger (43'C)(warm touch, COVIDIEN, full body blanket) for 10 minutes in the preanesthetic unit prior to induction of anesthesia. During operation, prewarmed intravenous fluid which was stored in the warming cabinet for more than 8 hours is connected and infused. Forced air blanket (warm touch, COVIDIEN, upper body blanket) with 38'C is applied for all patients during the operation.

干预措施: prewarming and warmed fluid infusion (Other)

no warming group

No Intervention

No warming group patients are not applied prewarming devices. Intravenous fluid stored in room air is connected and infused during the operation. Forced air blanket (warm touch, COVIDIEN, upper body blanket) with 38'C is applied for all patients during the operation.

结局指标

主要结局

incidence of hypothermia at the end of the operation

时间窗: approximately 1-2hours after induction (at the end of operation)

after completion of the operation, number of patients with hypothermia (\<36'C) using esophageal stethoscope will be recorded.

次要结局

  • change in temperature before and end of operation(on arrival at the OR upto 1-2hours after induction (at the end of the operation))
  • thermal comfort(upto 1hour after end of the operation (at discharge of postanesthesia care unit))
  • incidence of shivering(upto 1 hour after end of the operation (on arrival at the postanesthesia care unit))

研究者

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

In-Jung Jun

MD. PhD. associate Professor

Inje University

研究点 (1)

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