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Phase 4
Age: 18Years - 60Years
All Genders
ID06777966

Comparing Nebulized and Intravenous Tranexamic Acid to Improve Surgical Field During Endoscopic Sinus Surgery in Adults Aged 18 to 60

Led by Cairo University · Updated on 2025-01-22

60

Participants Needed

1

Research Sites

2 weeks

Total Duration

AI-Summary

What this Trial Is About

This research investigates the effects of preoperative nebulized versus intravenous tranexamic acid on the quality of the surgical field and bleeding rates during endoscopic sinus surgeries. The study addresses challenges faced by anesthesiologists and surgeons caused by intraoperative bleeding in a limited surgical field surrounded by vital structures. Tranexamic acid, known for reducing surgical blood loss systemically, is being evaluated in its nebulized form to provide targeted local effects while potentially reducing systemic side effects. Participants are randomly assigned to receive either a preoperative nebulized dose of 500 mg tranexamic acid with a placebo intravenous drip or an intravenous dose of 15 mgkg tranexamic acid with a placebo nebulizer session. Both groups are treated under general anesthesia for endoscopic sinus surgeries. This randomized, triple-blind, controlled trial compares the two administration routes to assess their impact on surgical conditions. During the study, researchers will measure the mean Wormald intraoperative surgical field grading over 5 hours, total blood loss, bleeding rate, operation time, and monitor postoperative complications and bleeding up to 48 hours after surgery. The trial includes close monitoring for safety and effectiveness, and participants will be observed throughout the surgical and immediate postoperative period. The study is sponsored by Cairo University and is planned to run until July 2025.

CONDITIONS

Brief Title

Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries

Research Team

K

Kareem MA Nawwar, M.D.

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