Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score
NCT06725732 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2025-01-29
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.
Conditions
- Blood Loss, Surgical
Interventions
- DRUG
-
Tranexamic Acid (TXA)
To see if nebulised TXA is better to control blood loss in functional Endoscopic sinus surgery
- DRUG
-
Tranexamic Acid
To see if intravenous TXA is better to control blood loss in functional Endoscopic sinus surgery
Sponsors & Collaborators
-
Assiut University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-01-29
- Primary Completion
- 2025-12-01
- Completion
- 2026-01-01
- FDA Drug
- Yes
Countries
- Egypt
Study Locations
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