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临床试验/NCT06777966
NCT06777966已完成4 期

Effect of Preoperative Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries: a Randomized Controlled Comparative Study

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
The mean Wormald intraoperative surgical field grading

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

Intravenous group

Active Comparator

patients will receive intravenous tranexamic acid

干预措施: intravenous tranexamic acid (Drug)

Nebulized group

Active Comparator

patients will receive nebulized tranexamic acid

干预措施: nebulized tranexamic acid (Drug)

结局指标

主要结局

The mean Wormald intraoperative surgical field grading

时间窗: 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

次要结局

  • Total blood loss(5 hours)
  • Bleeding rate(5 hours)
  • Operation time(5 hours)
  • Postoperative complications(24 hours)
  • postoperative nasal bleeding(48 hours)
  • postoperative intervention(48 hours)

研究者

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

Kareem Mohammed Assem Nawwar

Lecturer

Cairo University

研究点 (1)

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