Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score
Recruiting now · Early Phase 1
Conditions studied: Blood Loss, Surgical
In brief
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.
Key facts
- Study ID
- NCT06725732
- Run by
- Assiut University
- People needed
- 90
- Starts
- 2025-01-29
- Expected to finish
- 2026-01-01
- Last updated by the study team
- 2025-01-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- • 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
Where it is running
- Main building, Assiut University Hospitals — Asyut, Egypt (enrolling)
Full record on ClinicalTrials.gov
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