RECRUITING

TIVA vs TXA in Sinus Surgery to Evaluate Operative Blood Loss and Surgical Field Quality

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Comparison of Inhalational Anesthesia With Intravenous Tranexamic Acid and Total Intravenous Anesthesia on Surgical Field Quality in Endoscopic Sinus Surgery

Quick Facts

Study Start:2023-01-01
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05639686

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * adults (age ≥18 years)
  2. * will undergo endoscopic sinus surgery at Our Lady of the Lake Regional Medical Center
  3. * includes patients who are undergoing endoscopic sinus surgery for myriad of indications, such as chronic rhinosinusitis, sinonasal tumors, and encephalocele repairs.
  4. * 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).
  1. * \<18 years of age
  2. * history of bleeding or coagulation disorder
  3. * currently receiving anticoagulation therapy
  4. * underlying condition with increased risk of thrombosis (e.g. antiphospholipid syndrome),
  5. * history of thromboembolic disorder
  6. * history of chronic kidney disease
  7. * known allergy to tranexamic acid

Contacts and Locations

Study Contact

Christine LeBoeuf, DNP
CONTACT
225-765-5956
christine.leboeuf@fmolhs.org
Leslie S Son, PhD
CONTACT
225-757-4165
Lson@lsuhsc.edu

Principal Investigator

Stephen Hernandez, MD
PRINCIPAL_INVESTIGATOR
LSU Health Sciences Center

Study Locations (Sites)

Our Lady of the Lake Hospital
Baton Rouge, Louisiana, 70808
United States

Collaborators and Investigators

Sponsor: Our Lady of the Lake Hospital

  • Stephen Hernandez, MD, PRINCIPAL_INVESTIGATOR, LSU Health Sciences Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2023-01-01
Study Completion Date2025-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Rhinosinusitis Chronic
  • Sinus Cancer
  • Sinus Polyp
  • Encephalocele