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临床试验/NCT07325773
NCT07325773招募中不适用

Effects of Magnesium Sulfate on Intraoperative Oxygenation and Lung Mechanics During One-Lung Ventilation: A Prospective Observational Study

Marmara University1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
104
试验地点
1
主要终点
Change in Intraoperative Oxygenation (PaO₂/FiO₂ Ratio)

研究概览

简要总结

This prospective observational study aims to evaluate the effects of intravenous magnesium sulfate on intraoperative oxygenation and lung mechanics in patients undergoing thoracic surgery with one-lung ventilation. Magnesium sulfate has been reported to have potential bronchodilatory and anti-inflammatory properties, which may improve gas exchange and respiratory mechanics during lung isolation.

In this study, patients who receive magnesium sulfate as part of standard anesthetic management will be compared with those who do not receive the drug. Oxygenation parameters, dynamic and static lung mechanics, airway pressures, and ventilation-related indices will be recorded throughout the intraoperative period. The findings of this study may help clarify whether magnesium sulfate provides measurable respiratory benefits during one-lung ventilation.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 to 80 years Scheduled for elective thoracic surgery performed with video-assisted thoracoscopic surgery (VATS) requiring one-lung ventilation under general anesthesia.
  • ASA physical status II-III Ability to provide informed consent Undergoing general anesthesia with double-lumen tube placement

排除标准

  • Patients undergoing pneumonectomy
  • Patients with renal, hepatic, or cardiovascular failure
  • Patients with a BMI < 15 kg/m² or > 35 kg/m²
  • Patients with a preoperative pulmonary function test showing FEV₁ < 1.5 liters
  • Patients who are transferred to the intensive care unit intubated in the postoperative period
  • Patients with physical or mental conditions that prevent the performance of pulmonary function testing factors

研究组 & 干预措施

Group 1 - Magnesium Sulfate Group Label: Magnesium Sulfate Group

Patients receiving intravenous magnesium sulfate during the surgery as part of standard anesthetic management.

Group 2 - Control Group Label: Control Group

Patients undergoing one-lung ventilation without the administration of magnesium sulfate

结局指标

主要结局

Change in Intraoperative Oxygenation (PaO₂/FiO₂ Ratio)

时间窗: From induction of anesthesia to the end of one-lung ventilation (approximately 2-3 hours)

The PaO₂/FiO₂ ratio will be measured to evaluate intraoperative oxygenation during the surgery. Measurements will be recorded after induction of anesthesia (baseline) and at predefined intraoperative time points. The primary outcome is the change in PaO₂/FiO₂ ratio between baseline and intraoperative measurements in patients receiving magnesium sulfate versus control.

次要结局

  • Changes in Airway Pressures (Peak and Plateau Pressures)(From induction of anesthesia to the end of one-lung ventilation (approximately 2-3 hours).)
  • Dynamic Lung Compliance and Airway Resistance (Raw)(Intraoperative period (approximately 2-3 hours).)
  • Postoperative Arterial Oxygen Partial Pressure (PaO₂) on Room Air(Within the first postoperative hour while breathing room air.)

研究者

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

Meliha Orhon

Associate Professor

Marmara University

研究点 (1)

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