drugset / Trial / NCT06725732
Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score
RandomizedParallel-groupDouble-blindHealth-services research
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.
Timeline
- Start
- 2025-01-29
- Primary completion
- 2025-12-01
- Completion
- 2026-01-01
Publications
- Background Kang H, Hwang SH. Does topical application of tranexamic acid reduce intraoperative bleeding in sinus surgery during general anesthesia? Braz J Otorhinolaryngol. 2020 Jan-Feb;86(1):111-118. doi: 10.1016/j.bjorl.2019.08.006. Epub 2019 Oct 3.
- Background Khosla AJ, Pernas FG, Maeso PA. Meta-analysis and literature review of techniques to achieve hemostasis in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Jun;3(6):482-7. doi: 10.1002/alr.21126. Epub 2012 Dec 16.
- Background Kim DH, Kim S, Kang H, Jin HJ, Hwang SH. Efficacy of tranexamic acid on operative bleeding in endoscopic sinus surgery: A meta-analysis and systematic review. Laryngoscope. 2019 Apr;129(4):800-807. doi: 10.1002/lary.27766. Epub 2018 Dec 28.
- Results Alicandri-Ciufelli M, Pingani L, Mariano D, Anschuetz L, Molinari G, Marchioni D, Bonali M, Galeazzi GM, Presutti L. Rating surgical field quality in endoscopic ear surgery: proposal and validation of the "Modena Bleeding Score". Eur Arch Otorhinolaryngol. 2019 Feb;276(2):383-388. doi: 10.1007/s00405-018-05268-6. Epub 2019 Jan 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranexamic Acid | Small molecule | — | Inhaled |
Indications
No indication recorded.