Actively Recruiting
Effect of Preoperative Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries: a Randomized Controlled Comparative Study
Led by Cairo University · Updated on 2025-01-22
60
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
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 mg/kg 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years
- American Society of Anesthesiologists (ASA) class I and II patients
- Scheduled for endoscopic sinus surgeries under general anesthesia
You will not qualify if you...
- Patient's refusal to participate
- American Society of Anesthesiologists (ASA) class III or IV patients
- Uncontrolled hypertension
- Known bleeding disorders
- Current use of anticoagulant therapy
- Allergy to any study medications
- Use of nonsteroidal anti-inflammatory drugs within 48 hours before surgery
- Inadvertent vascular injury during surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Preoperative period on the day of surgery
Participants receive a preoperative dose of tranexamic acid via nebulizer or intravenous drip before their endoscopic sinus surgery.
1 treatment visit (in-person)
Duration - Up to 48 hours after surgery
Participants are monitored for surgical field quality, blood loss, bleeding rate, operation time, and postoperative complications including nasal bleeding and interventions.
Approximately 2 follow-up visits within 48 hours post-surgery
Trial Site Locations
Total: 1 location
1
Faculty of Medicine, Cairo University
Cairo, Egypt
Actively Recruiting
Research Team
K
Kareem MA Nawwar, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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