Does topical application of tranexamic acid reduce intraoperative bleeding in sinus surgery during general anesthesia?
Haram Kang, Se Hwan Hwang
https://pubmed.ncbi.nlm.nih.gov/31653606Actively Recruiting
Early Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06725732
Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score A Randomized Double Blinded Controlled Trial
Led by Assiut University · Updated on 2025-01-29
90
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of preoperative intravenous and nebulized tranexamic acid on patients undergoing functional endoscopic sinus surgery (FESS), a common treatment for conditions affecting the nasal cavity and paranasal sinuses. The study aims to assess how these treatments impact surgical field visibility using the Modena Bleeding Score, blood loss, anesthetic use, and patient hemodynamics. It also monitors potential postoperative complications such as nausea, vomiting, visual disturbances, seizures, and clotting events. Participants will receive either intravenous or nebulized tranexamic acid before surgery to compare their effects on controlling bleeding during FESS. Tranexamic acid works by inhibiting fibrinolysis, which helps reduce bleeding. The study evaluates the two methods of administration to determine which better improves the surgical experience for both surgeons and patients. Throughout the study, participants' vital signs like blood pressure, respiratory rate, temperature, pulse, oxygen saturation, and end-tidal CO2 will be monitored. Researchers will measure intraoperative bleeding by blood volume collected and gauze count, track anesthetic consumption including extra doses of fentanyl, propofol, and sevoflurane, and observe any postoperative complications. The trial includes regular assessments to evaluate safety and effectiveness, with participation lasting through the surgical procedure and immediate recovery period.
CONDITIONS
Brief Title
Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score
Who Can Participate
Age: 18Years - 65Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Participants of either sex
- Aged between 18 and 65 years
- Classified as ASA I or II and listed for elective functional endoscopic sinus surgery under general anesthesia
- Have normal coagulation profile and hematocrit value of 30 or higher
You will not qualify if you...
- Chronic renal failure
- Liver cirrhosis
- Bleeding disorders
- Current anticoagulant therapy
- Pregnancy or breastfeeding
- Impaired color vision
- Severe vascular ischemia
- History of venous thrombosis or pulmonary embolism
- Long-term use of acetylsalicylic acid or non-steroidal anti-inflammatory drugs not stopped before surgery
- Hemoglobin concentration less than 10 mg/dl
- Allergy to tranexamic acid
- Body mass index over 35 kg/m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Surgery day
Participants receive nebulized or intravenous tranexamic acid during functional endoscopic sinus surgery to control blood loss and improve surgical conditions.
1 visit (in-person, surgery day)
Post-operative Follow-up
Duration - Post-surgery recovery period
Participants are monitored for post-operative complications such as nausea, vomiting, and visual disturbances following surgery.
Approximately 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Main building, Assiut University Hospitals
Asyut, Egypt
Actively Recruiting
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Research Team
A
Asmaa Shabaan Zanaty, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Published Research Related To This Trial
Meta-analysis and literature review of techniques to achieve hemostasis in endoscopic sinus surgery.
Akhil J Khosla, Francisco G Pernas, Patricia A Maeso
https://pubmed.ncbi.nlm.nih.gov/23255493Efficacy of tranexamic acid on operative bleeding in endoscopic sinus surgery: A meta-analysis and systematic review.
Do Hyun Kim, Subin Kim, Haram Kang...
https://pubmed.ncbi.nlm.nih.gov/30593688Rating surgical field quality in endoscopic ear surgery: proposal and validation of the "Modena Bleeding Score".
Matteo Alicandri-Ciufelli, Luca Pingani, Davide Mariano...
https://pubmed.ncbi.nlm.nih.gov/30604058