Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score
Launched by ASSIUT UNIVERSITY · Dec 9, 2024
Trial Information
Current as of June 04, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring the effects of a medication called tranexamic acid, which can be given either through an IV or as a mist (nebulized), on patients undergoing a specific type of surgery for sinus problems called Functional Endoscopic Sinus Surgery (FESS). The main goal of the study is to see if this medication helps reduce bleeding during surgery and how it affects the overall surgical experience, including the amount of anesthesia needed and the patient’s vital signs.
To be eligible for this trial, participants should be between 18 and 65 years old, generally healthy (classified as ASA I-II), and scheduled for elective FESS surgery. They should not have certain health issues like chronic kidney disease, liver disease, or bleeding disorders, and should not be pregnant or breastfeeding. Those who join the study can expect close monitoring during and after the surgery, and they will be observed for any side effects from the medication, such as nausea or unusual reactions. This research aims to improve surgical outcomes and patient safety for those undergoing sinus surgery.
Gender
ALL
Eligibility criteria
- 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
About Assiut University
Assiut University, a prominent academic institution located in Egypt, is dedicated to advancing medical research and clinical trials that enhance healthcare outcomes. With a strong emphasis on innovation and collaboration, the university engages in a wide array of clinical studies across various disciplines, aiming to contribute valuable insights into disease prevention, diagnosis, and treatment. Assiut University's commitment to ethical research practices and rigorous scientific methodology ensures the integrity and reliability of its clinical trials, ultimately benefiting both the local community and the global medical landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Assiut, , Egypt
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported