Comparing two anesthesia methods in sinus surgery
Comparison of Inhalational Anesthesia With Intravenous Tranexamic Acid and Total Intravenous Anesthesia on Surgical Field Quality in Endoscopic Sinus Surgery
This study is testing whether total intravenous anesthesia or a combination of inhaled anesthesia with a blood-loss reducing medication works better for patients having sinus surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Our Lady of the Lake Hospital Academic / other |
| Locations | 1 site (Baton Rouge, Louisiana) |
| Trial ID | NCT05639686 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to compare the effectiveness of total intravenous anesthesia (TIVA) versus general inhalational anesthesia combined with intravenous tranexamic acid (TXA) in patients undergoing endoscopic sinus surgery. Participants will be randomly assigned to receive either TIVA alone or TXA with inhalational anesthesia, and the study will evaluate surgical field quality and intraoperative blood loss. Additionally, a cost analysis will be conducted to determine the financial advantages of each anesthesia method. The study will be conducted at Our Lady of the Lake Regional Medical Center, ensuring a controlled and systematic approach to data collection.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for endoscopic sinus surgery for conditions like chronic rhinosinusitis or sinonasal tumors.
Not a fit: Patients with bleeding disorders, those on anticoagulation therapy, or individuals under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced blood loss during sinus surgeries.
How similar studies have performed: While the specific combination of TIVA and TXA in this context is novel, previous studies have shown that both methods can be effective in managing surgical conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baton Rouge, Louisiana
- Our Lady of the Lake Hospital — Baton Rouge, Louisiana, United States (Recruiting)
Study contacts
- Principal investigator: Stephen Hernandez, MD — LSU Health Sciences Center
- Study coordinator: Christine LeBoeuf, DNP
- Email: christine.leboeuf@fmolhs.org
- Phone: 225-765-5956
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.