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临床试验/NCT06245148
NCT06245148已完成不适用

The Effect of Intraoperative Ephedrine Use on the Incidence of Hypothermia After Major Surgery

Acibadem University1 个研究点 分布在 1 个国家目标入组 9,259 人开始时间: 2019年1月2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
9,259
试验地点
1
主要终点
Incidence of Hypothermia after Major Surgery

研究概览

简要总结

Intraoperative hypothermia is a common and potentially severe complication during major surgical procedures. The consequences of intraoperative hypothermia can be far-reaching, affecting patient outcomes, recovery times, and overall healthcare costs. Therefore, strategies aimed at preventing hypothermia are of paramount importance in modern surgical practice. However, despite all the measures taken, some patients may still become hypothermic at the end of surgery. Understanding these factors can enhance the quality of daily practice. Medications used intraoperatively can decrease the threshold for vasoconstriction, and some of them have been reported to influence thermoregulation. For example, ephedrine is a sympathomimetic amine used to maintain hemodynamic stability, but there is a report about its thermogenic effect. One study found that patients who received an intraoperative infusion of ephedrine had a significantly lower decrease in core temperature and these patients had a more stable hemodynamic profile. It was employed in obese patients for its thermogenic and appetite-suppressing effects until its adverse effects prevented its use. Ephedrine has an unintended yet significant effect on body temperature regulation, which has raised questions about its role in contributing to the incidence of hypothermia in the postoperative period. The purpose of this study is to investigate the potential relationship between the intraoperative use of ephedrine and the incidence of hypothermia following major surgery.

详细描述

This study aims to investigate the potential relationship between the intraoperative use of ephedrine and the incidence of hypothermia following major surgery. The primary goal is to determine the effect of intraoperative ephedrine use on the incidence of hypothermia after major surgery. The secondary goal is to identify patient characteristics associated with an increased risk of hypothermia despite all measures taken. The results of this study could have important implications for the quality of care for patients undergoing major surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

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

入选标准

  • all adult patients (age 18 years) who received ephedrine during general anesthesia undergoing major surgical procedures

排除标准

  • Patients undergoing minor surgical procedures
  • Patients scheduled for day surgeries
  • Patients patients (those under the age of 18)
  • Patients with a history of thyroid disease
  • Patients undergoing brain surgery
  • Patients undergoing radiological interventions,
  • Trauma patients
  • Patients directly transferred from the intensive care unit to the operating room
  • Patients with preoperative fever (either low or high)
  • Patients who have received vasoactive agents within 24 hours before surgery
  • Patients with sepsis and/or septic shock, or fever within a week before surgery
  • Patients who have received vasoactive agents

结局指标

主要结局

Incidence of Hypothermia after Major Surgery

时间窗: From anesthesia induction until discharge to a ward, with the event defined as the time the patient meets all discharge criteria, assessed up to 10 hours post-operatively.

The occurrence of hypothermia in patients who have undergone major surgery, specifically comparing those who received intraoperative ephedrine to those who did not.

次要结局

  • Patient Characteristics Associated with Increased Hypothermia Risk(From anesthesia induction until discharge to a ward, with the event defined as the time the patient meets all discharge criteria, assessed up to 10 hours post-operatively.)

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lerzan Doğan

Dr

Acibadem University

研究点 (1)

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