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临床试验/NCT05636189
NCT05636189已完成不适用

Effect of Prewarming During Induction of General Anesthesia Combined With Warmed Intravenous Fluid on Core Temperature in Patients Undergoing Urologic Surgery.

Inje University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年11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
50
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 during induction of general anesthesia during urologic surgery.

详细描述

Hypothermia is of continuous issue in patients undergoing general anesthesia. During urologic operation (transurethral resection of bladder and prostate), bladder irrigation worsens hypothermia. Hence, various methods including prewarming of the patient are used to maintain core temperature during operation.

Prewarming is found to be effective in maintaining core temperature perioperatively by increasing peripheral tissue heat content. However, applying more than 30 minutes of prewarming may be impractical as a clinical routine practice. Hence, developing simple and effective method to prevent hypothermia is expected.

Here, the investigators planned to examine the effect of active warming (10 minutes of warming during induction of general anesthesia 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
  • •previous 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 of the patient with whole body warming blanket in the OR during induction of anesthesia, prewarmed intravenous fluid during the operation.

干预措施: Prewarmed intravenous fluid administration (Procedure)

no warming group

No Intervention

There will be no whole body warming during induction.

warming group

Active Comparator

warming of the patient with whole body warming blanket in the OR during induction of anesthesia, prewarmed intravenous fluid during the operation.

干预措施: warming during induction of anesthesia (Procedure)

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)

number of patients with hypothermia (\<36'C) using esophageal stethoscope will be recorded.

次要结局

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

研究者

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

In-Jung Jun

assistant professor

Inje University

研究点 (1)

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