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临床试验/NCT06847659
NCT06847659尚未招募不适用

Comparison of the Effect of Prewarming on Intraoperative Hypothermia in Patients Undergoing HoLEP (Holmium Laser Prostatectomy) Surgery

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2025年3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
尚未招募
入组人数
106
试验地点
1
主要终点
Time to onset of intraoperative hypothermia.

研究概览

简要总结

This study aims to evaluate the effectiveness of prewarming methods in preventing intraoperative hypothermia in patients undergoing HoLEP surgery. Designed as a randomized controlled study, patients who receive prewarming will be compared with those in the control group.

研究设计

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

入排标准

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

入选标准

  • •Male patients aged 18 years and older
  • •Patients undergoing HoLEP surgery under general anesthesia
  • •Patients who consent to participate in the study

排除标准

  • •Patients who refuse to participate in the study.
  • •Patients unable to read, understand, or sign the informed consent form.
  • •Hemodynamically unstable patients.
  • •Patients with a preoperative or intraoperative body temperature >37°C.

研究组 & 干预措施

Prewarming Group

Experimental

Patients will receive 10 minutes of 43°C forced-air warming and 41°C prewarmed intravenous fluid before surgery. Surgery will begin following the standard induction of general anesthesia once patients are in the operating room. An air blower set to 43°C will maintain patient warmth throughout the procedure.

干预措施: intraoperative body temperature (Diagnostic Test)

Control Group

Other

No prewarming will be applied. Surgery will begin following the standard induction of general anesthesia once patients are in the operating room. An air blower set to 43°C will maintain patient warmth throughout the procedure.

干预措施: intraoperative body temperature (Diagnostic Test)

结局指标

主要结局

Time to onset of intraoperative hypothermia.

时间窗: intraoperatively

Time to develop intraoperative hypothermia (when body temperature drops below 36°C)

次要结局

  • Hemodynamic parameters(intraoperatively)
  • Volume of irrigation fluid used(intraoperatively)
  • Changes in body temperature(intraoperatively)
  • respiratory parameter(intraoperatively)

研究者

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

Betül Güven

Ankara City Hospital Bilkent

Ankara City Hospital Bilkent

研究点 (1)

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