RecruitingEarly Phase 1NCT06725732

Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score

Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score. a Randomized Double Blinded Controlled Trial.


Sponsor

Assiut University

Enrollment

90 participants

Start Date

Jan 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study is to investigate the effect of preoperative administration of intravenous or nebulized tranexamic acid on surgical field, blood loss, anesthetic consumption and hemodynamics of patients undergoing FESS. Primary outcome Modena Bleeding Score (MBS) assessing surgical field Secondary outcome 1. Patient hemodynamics. 2. Anesthetic consumption, Extra doses of fentanyl and propofol and sevoflurane\>2 3. Postoperative complications: including any adverse effects to TXA e.g.nausea, vomiting, any visual disturbances, fits, and any thrombotic manifestation.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • Either sex
  • age 18-65 years
  • 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 Criteria11

  • • 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.
  • BMI \> 35 kg/ m2

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Interventions

DRUGTranexamic Acid (TXA)

To see if nebulised TXA is better to control blood loss in functional Endoscopic sinus surgery

DRUGTranexamic Acid

To see if intravenous TXA is better to control blood loss in functional Endoscopic sinus surgery


Locations(1)

Main building, Assiut University Hospitals

Asyut, Egypt

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NCT06725732


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