TIVA vs TXA in Sinus Surgery to Evaluate Operative Blood Loss and Surgical Field Quality
Launched by OUR LADY OF THE LAKE HOSPITAL · Nov 28, 2022
Trial Information
Current as of January 14, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at two different types of anesthesia used during endoscopic sinus surgery, which is a procedure to treat conditions like chronic sinus infections, sinus tumors, and certain birth defects in the sinuses. The study compares total intravenous anesthesia (TIVA), which is given through an IV, to a combination of IV tranexamic acid (TXA) and general inhaled anesthesia. Researchers want to find out if one method provides a better view of the surgical area and less blood loss during surgery, and also which option is more cost-effective for patients and hospitals.
To participate in this trial, you need to be an adult (at least 18 years old) and scheduled for endoscopic sinus surgery at Our Lady of the Lake Regional Medical Center. If you have certain medical conditions, like a bleeding disorder or are on blood thinners, you may not be eligible. If you join, you will be randomly assigned to one of the two anesthesia groups before your surgery. The study aims to gather information on how well each anesthesia method works, so your experience may help improve future patient care.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • adults (age ≥18 years)
- • will undergo endoscopic sinus surgery at Our Lady of the Lake Regional Medical Center
- • includes patients who are undergoing endoscopic sinus surgery for myriad of indications, such as chronic rhinosinusitis, sinonasal tumors, and encephalocele repairs.
- • includes patients who undergo both complete functional endoscopic sinus surgery, or FESS (i.e maxillary antrostomy, sphenoethmoidectomy, and frontal sinusotomy), as well as those who are undergoing limited functional endoscopic sinus surgeries (i.e. anything less than a complete FESS).
- Exclusion Criteria:
- • \<18 years of age
- • history of bleeding or coagulation disorder
- • currently receiving anticoagulation therapy
- • underlying condition with increased risk of thrombosis (e.g. antiphospholipid syndrome),
- • history of thromboembolic disorder
- • history of chronic kidney disease
- • known allergy to tranexamic acid
Trial Officials
Stephen Hernandez, MD
Principal Investigator
LSU Health Sciences Center
About Our Lady Of The Lake Hospital
Our Lady of the Lake Hospital is a leading healthcare institution dedicated to advancing medical research and improving patient care through clinical trials. With a commitment to innovation and excellence, the hospital collaborates with a diverse range of healthcare professionals and researchers to explore new therapies and treatment modalities. As a trusted sponsor, Our Lady of the Lake Hospital prioritizes the safety and well-being of participants while contributing to the development of evidence-based practices that enhance health outcomes in the community and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Baton Rouge, Louisiana, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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