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NCT05639686
TIVA vs TXA in Sinus Surgery to Evaluate Operative Blood Loss and Surgical Field Quality
Conditions: Rhinosinusitis Chronic, Sinus Cancer, Sinus Polyp, Encephalocele
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 100
Sponsor: Our Lady of the Lake Hospital
Summary
The goal of this interventional study is to compare the efficacy (surgical field quality and intra-operative blood loss) or cost of TIVA alone to general inhalational anesthetics with intravenous TXA in patient participants who are undergoing endoscopic sinus surgery.The main questions the study aims to answer are:Is the surgical field quality better when using TIVA alone compared to general inhalational anesthetics with intravenous TXA?Is one method more financially advantageous to the participant and the institution compared to the other method?Participants will be randomized into one of the two anesthesia cohorts prior to sinus surgery.
One group will be given total intravenous anesthesia (TIVA) alone and the other will be given intravenous tranexamic acid (TXA) followed by general inhalational anesthesia.Researchers will compare the TIVA group to the TXA group to see if one group exhibits a better surgery field viewing quality through a subjective evaluation and measurement of blood loss and also which anesthesia regimen is most cost effective upon conducting a cost analysis.
Eligibility Criteria
Inclusion Criteria:adults (age ≥18 years)will undergo endoscopic sinus surgery at Our Lady of the Lake Regional Medical Centerincludes 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 agehistory of bleeding or coagulation disordercurrently receiving anticoagulation therapyunderlying condition with increased risk of thrombosis (e.g.
antiphospholipid syndrome),history of thromboembolic disorderhistory of chronic kidney diseaseknown allergy to tranexamic acid
Source: ClinicalTrials.gov (NCT05639686). StuddyBuddy aggregates publicly available trial information.