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Recruiting Early Phase 1

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

NCT06725732 · tracked via the Priya Life Science Egypt tracker
Phase
Early Phase 1
Started
2025-01-29
Last updated
2025-01-29

Condition(s) studied

Blood Loss, Surgical

Investigational drug(s) / intervention(s)

Tranexamic Acid (TXA) →Tranexamic Acid →

Tranexamic Acid (TXA): To see if nebulised TXA is better to control blood loss in functional Endoscopic sinus surgery

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

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Either sex 2. age 18-65 years 3. ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia 4. normal accepted coagulation profile and hematocrit value ≥30 Exclusion Criteria: * • 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

Primary outcome measure(s)

  • Modena Bleeding Score- assessing surgical field — Baseline
    * No bleeding -\>1. * Bleeding easily controlled by suctioning, washing, or packing without any significant modification or slowing of surgical procedure-\>2. * Bleeding slowing surgical procedure-\>3. * Most of the maneuvers dedicated to bleeding control -\>4. * Bleeding that prevents every surgical procedure except those dedicated to bleeding control-\>5.

Trial sites (1)

FacilityCityRegionStatus
Main building, Assiut University Hospitals Asyut Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06725732 on ClinicalTrials.gov ↗ ← All trials in Egypt