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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 February 05, 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.

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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