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雾化与静脉注射氨甲环酸对接受内窥镜鼻窦手术患者手术视野质量的影响

2026年9月19日 更新者:Kareem Mohammed Assem Nawwar、Cairo University

术前雾化与静脉注射氨甲环酸对接受内窥镜鼻窦手术患者手术视野质量的影响:一项随机对照比较研究

Intraoperative bleeding is one of the vital problems for anesthesiologists and surgeons, during endoscopic nasal surgery; where the surgical field is very limited and surrounded by vital structures. The tinniest amount of blood in such surgical field can obscure the anatomy and clog the tip of the endoscope, requiring repeated irrigations and suctioning; both of which have traumatic effects on the friable nasal mucosa. Anesthetic techniques to minimize bleeding during endoscopic nasal surgery are of primary importance for a safe and effective procedure, reducing operative time and shortening post-operative recovery.

Good surgical conditions could be achieved with systemic, topical, or regional anesthetic techniques. The use of topical and regional techniques has been gaining popularity in recent years as an alternative to the administration of heavy premedication, high narcotic doses, intravenous lignocaine, clonidine, calcium channel blockers, sodium nitroprusside, beta-adrenergic blockers, and magnesium sulfate, which may produce a lack of alertness, respiratory depression, hypoxia, nausea and vomiting, and delayed recovery.

Recent studies have shown that the use of tranexamic acid could be a safe and effective management option for hemostasis in a wide range of specialties. Tranexamic acid (TXA) is a synthetic lysine derivative that blocks the lysine binding site on plasminogen, thus inactivating its conversion to plasmin and hence attenuating its fibrinolysis effects. When given as a one-time operative systemic dose, it can reduce intraoperative surgical blood loss. More recently, it has been used in its nebulized or topical form to treat bleeding in anatomically sequestered areas. Its use has been described for epistaxis, cancer-related hemoptysis, and post-tonsillectomy bleeding. Though systemic doses of tranexamic acid have proven their efficiency in reducing intraoperative bleeding, other forms of administration have not been widely researched. The use of nebulized form is expected to provide a targeted route and localized effect with reduced systemic side effects. Adverse effects of systemic administration of tranexamic acid include seizures, nausea, vomiting, diarrhea, pulmonary embolism, deep vein thrombosis, anaphylaxis, and other visual disturbance.

The purpose of this study was to assess the effect of pre-emptive nebulized tranexamic acid versus intravenous tranexamic acid on endoscopic visualization and bleeding rate during endoscopic sinus surgeries.

研究概览

研究类型

介入性

注册 (实际的)

60

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Cairo Governorate
      • Cairo、Cairo Governorate、埃及
        • Faculty of Medicine, Cairo University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age between 18 and 60 years.
  • American Society of Anesthesiologists (ASA) class I and II patients.
  • Endoscopic sinus surgeries under general anesthesia.

Exclusion Criteria:

  • Patient's refusal.
  • American Society of Anesthesiologists (ASA) class III or IV patients.
  • Underlying uncontrolled hypertension.
  • Known history bleeding disorder.
  • Patients on anticoagulant therapy.
  • Allergy to any of the drugs utilized in this study.
  • History of nonsteroidal anti-inflammatory drugs within 48 hours of scheduled surgery.
  • Inadvertent intra-operative vascular injury.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器:Nebulized group

patients will receive nebulized tranexamic acid

patients will receive a preoperative nebulizer session of 500 mg of tranexamic acid. To ensure the blinding of the participating anesthetist and patient, patients in this group will receive an intravenous drip of 100 ml of 0.9% normal saline.

有源比较器:Intravenous group

patients will receive intravenous tranexamic acid

patients will receive a preoperative intravenous drip of TXA at a dose of 15 mg/kg in 100 ml of normal saline. To ensure blinding this group patients will receive 5 ml of 0.9% normal saline nebulizer session.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The mean Wormald intraoperative surgical field grading
大体时间:5 hours

The mean value of Wormald intraoperative surgical field grading throughout the intraoperative period, where 0 means no bleeding and 10 means severe bleeding with nasal cavity filling rapidly

5 hours

次要结果测量

结果测量
措施说明
大体时间
Total blood loss
大体时间:5 hours

calculated by measuring the volume of the blood in the suction reservoir minus the normal saline used to wash the surgical field

5 hours
Bleeding rate
大体时间:5 hours

calculated as the total blood loss divided by the surgical time

5 hours
Operation time
大体时间:5 hours

Time starting from induction of anesthesia till completion of the surgical procedure

5 hours
Postoperative complications
大体时间:24 hours

nausea, vomiting, anaphylaxis, visual impairment, seizure, venous thromboembolism

24 hours
postoperative nasal bleeding
大体时间:48 hours

Incidence of postoperative nasal bleeding

48 hours
postoperative intervention
大体时间:48 hours

Incidence of the need for postoperative intervention to control nasal bleeding

48 hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Kareem MA Nawwar, M.D.、Cairo University
  • 学习椅:Nevan M Abbas Elmekawy, M.D.、Cairo University
  • 研究主任:Tamer M Khair, M.D.、Cairo University
  • 首席研究员:Nadia E M Gaballah, M.Sc.、Cairo University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年1月24日

初级完成 (实际的)

2025年7月30日

研究完成 (实际的)

2025年8月10日

研究注册日期

首次提交

2025年1月11日

首先提交符合 QC 标准的

2025年1月11日

首次发布 (实际的)

2025年1月16日

研究记录更新

最后更新发布 (实际的)

2026年9月22日

上次提交的符合 QC 标准的更新

2026年9月19日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • MD-206-2024

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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