Recruiting

TIVA vs. TXA

Sponsor:

Our Lady of the Lake Hospital

Code:

NCT05639686

Conditions

Rhinosinusitis Chronic

Sinus Cancer

Sinus Polyp

Encephalocele

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Tranexamic acid injection

Total Intravenous Anesthesia

Inhalational isoflurane

Study Details

Brief 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.

Conditions

Rhinosinusitis Chronic

Sinus Cancer

Sinus Polyp

Encephalocele

Study ID

NCT05639686

Start date

Jan 1, 2023

Status verified date

Mar, 2023

Completion date

Jul 1, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Total Intravenous Anesthesia (TIVA)

Patients will be induced with fentanyl 1-2µg/kg, propofol 2mg/kg, and lidocaine 1mg/kg. After orotracheal intubation, anesthesia will be maintained with propofol 150mg/kg/min, remifentanil 0.05-2µg/kg/min, and rocuronium or succinylcholine as indicated. This is standard of care for this procedure. Within 10 minutes of induction, patients in the control group will be administered a 100mL bolus of normal saline as placebo.

experimental: Transexemic Acid (TXA) and Inhalational Anesthesia

Patients will be induced with fentanyl 1-2µg/kg, propofol 2mg/kg, lidocaine 1mg/kg. After orotracheal intubation, anesthesia will be maintained with isoflurane 1.5-2% or sevoflurane 1-2%, as well as rocuronium or succinylcholine as indicated. Again standard of care procedure is applied. Within 10 minutes of induction, patients in the study group will be administered 15mg/kg TXA suspended in 100mL of normal saline intravenously.

Interventions

Tranexamic acid injection

Within 10 minutes of general anesthetic induction, 15mg/kg TXA suspended in 100mL of normal saline will be administered intravenously.

Total Intravenous Anesthesia

Within 10 minutes of induction, patients in the control (TIVA) group will be administered a 100mL bolus of normal saline as placebo.

Inhalational isoflurane

Inhalational isoflurane or sevoflurane will be administered as a general anesthetic at the induction of the surgical procedure.

Primary outcome measure

  • Surgical Field Quality [ Time Frame: Field quality measured Every 30 minutes over 4.5 hours of time using the Boezaart grading system. ]
  • Intraoperative Blood loss [ Time Frame: Measured once at the conclusion of surgery by measuring the total amount of fluid in the suction canisters minus the total amount of irrigation used ]

Central Contacts and Locations

Central contacts

Christine LeBoeuf, DNP

225-765-5956christine.leboeuf@fmolhs.org

Leslie S Son, PhD

225-757-4165Lson@lsuhsc.edu

Locations

Our Lady of the Lake Hospital

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Leslie Son, Ph.D.

225-757-4165lson@lsuhsc.edu

Christine LeBoeuf, DNP

225-765-5956christine.leboeuf@fmolhs.org

More Information

Sponsor

Our Lady of the Lake Hospital

Last update posted

Mar 23, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Our Lady of the Lake Hospital on 2023-03-23.