Comparing nebulized and intravenous tranexamic acid for better surgical conditions in sinus surgeries
Effect of Preoperative Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries: a Randomized Controlled Comparative Study
This study is testing whether using a breathing treatment or an IV medication can help improve the surgical conditions and reduce bleeding during sinus surgeries for adults aged 18 to 60.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06777966 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of nebulized versus intravenous tranexamic acid in improving surgical field quality during endoscopic sinus surgeries. It aims to reduce intraoperative bleeding, which can obscure visibility and complicate the procedure. By comparing these two methods, the study seeks to determine which approach provides better outcomes for patients undergoing this type of surgery. The trial includes patients aged 18 to 60 years who are classified as ASA class I and II and are undergoing general anesthesia for endoscopic sinus surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 years classified as ASA class I and II who are scheduled for endoscopic sinus surgery.
Not a fit: Patients with ASA class III or IV, uncontrolled hypertension, bleeding disorders, or those on anticoagulant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical conditions and reduced recovery times for patients undergoing endoscopic sinus surgeries.
How similar studies have performed: While the specific approach of comparing nebulized and intravenous tranexamic acid is novel, similar studies have shown that minimizing intraoperative bleeding can significantly improve surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 60 years. * American Society of Anesthesiologists (ASA) class I and II patients. * Endoscopic sinus surgeries under general anesthesia. Exclusion Criteria: * Patient's refusal. * American Society of Anesthesiologists (ASA) class III or IV patients. * Underlying uncontrolled hypertension. * Known history bleeding disorder. * Patients on anticoagulant therapy. * Allergy to any of the drugs utilized in this study. * History of nonsteroidal anti-inflammatory drugs within 48 hours of scheduled surgery. * Inadvertent intra-operative vascular injury.
Where this trial is running
Cairo
- Faculty of Medicine, Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Nadia E M Gaballah, M.Sc. — Cairo University
- Study coordinator: Kareem MA Nawwar, M.D.
- Email: drknawwar@cu.edu.eg
- Phone: +201003878369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.