RecruitingPhase 3NCT04905901

Nebulized Tranexamic Acid in Sinus Surgery

Does Nebulized Tranexamic Acid Affect Operative Field in Sinus Surgery? A Double Blind Randomized Clinical Trial


Sponsor

Assiut University

Enrollment

90 participants

Start Date

May 6, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The results of several recent studies on endoscopic sinus surgery through topical administration of tranexamic acid are encouraging in terms of the efficacy of tranexamic acid for intraoperative bleeding and other pathological conditions.The purpose of this study is to analyze the efficacy of nebulized tranexamic acid to improve the surgeon and patient experiences of sinus surgery and know the effective and safe dose of nebulized tranexamic acid.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

  • Either sexes (age 18-65 years) of ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia
  • normal accepted coagulation profile and hematocrit value ≥30

Exclusion Criteria10

  • chronic renal failure
  • liver cirrhosis
  • bleeding disorders
  • current anticoagulant therapy
  • pregnancy or breastfeeding
  • impaired color vision
  • severe vascular ischemia
  • history of venous thrombosis, pulmonary embolism
  • long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before surgery
  • hemoglobin (HB) concentration <10 mg/dl _allergy to TXA.

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Interventions

DRUGTranexamic acid

Tranexamic acid nebulization 15 minutes before sinus surgery

OTHERSaline placebo

Normal saline placebo nebulization 15 minutes before sinus surgery


Locations(1)

Assuit

Asyut, Assuit, Egypt

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NCT04905901