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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rhinosinusitis Chronic; Sinus Cancer; Sinus Polyp; Encephalocele
• Intervention / Treatment: Drug: Total Intravenous Anesthesia; Drug: Tranexamic acid injection; Drug: Inhalational isoflurane

Detailed Description

This study aims to prospectively compare surgical field quality and intraoperative blood loss between patients treated with perioperative intravenous tranexamic acid (TXA) followed by general inhalational anesthesia (sevoflurane, isoflurane, or desflurane) to total intravenous anesthesia (TIVA) alone, which consists of propofol and remifentanil. A secondary objective would be to perform a cost analysis between these two groups to determine whether one method is financially more advantageous than the other.

This study will be a prospective double-blinded randomized control trial consisting of patients undergoing endoscopic sinus surgery to assess intraoperative blood loss, surgical field quality, and cost of the medications administered. The control group will receive total intravenous anesthesia without tranexamic acid during surgery. The study group will receive preoperative tranexamic acid with general inhaled anesthetics during surgery (detailed below). Randomization will be conducted via a pre-determined permuted block system (e.g. AABB, ABAB, BBAA, AABB, etc, where A is TIVA and B is general inhalational anesthetics with preoperative TXA). Subjects who consent to participate will be assigned to the A or B arm depending on whichever arm is listed next in the order.

Subjects will be informed about the study and consented during pre-operative clinic visits. The patient consent and HIPAA authorization forms will be presented at that time where the subject can read about the study followed by any verbal conversation or questions needed between the subject and the study team. This will be done in a private patient room setting. The subject will be notified that participation in the study is completely voluntary and that their medical care will not be affected regardless of their decision to participate. Of note, if patients decline to participate, they will undergo general anesthesia using TIVA without TXA, as this is the standard choice at our institution. Subjects will not receive payment or compensation for their participation.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine LeBoeuf, DNP; Phone Number: 225-765-5956; Email: christine.leboeuf@fmolhs.org
• Study Contact Backup: Name: Leslie S Son, PhD; Phone Number: 225-757-4165; Email: Lson@lsuhsc.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting
      • Our lady of the Lake Hospital
      • Contact: Christine LeBoeuf, DNP; Phone Number: 225-765-5956; Email: christine.leboeuf@fmolhs.org
      • Contact: Leslie Son, Ph.D.; Phone Number: 225-757-4165; Email: lson@lsuhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 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.; Other Names: total intravenous anesthesia (propofol, remifentanil)
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.	Drug: Tranexamic acid injection; Within 10 minutes of general anesthetic induction, 15mg/kg TXA suspended in 100mL of normal saline will be administered intravenously.; Other Names: tranexamic acid (TXA); Drug: Inhalational isoflurane; Inhalational isoflurane or sevoflurane will be administered as a general anesthetic at the induction of the surgical procedure.; Other Names: Inhalational anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Field Quality	Surgical field quality during surgery	Field quality measured Every 30 minutes over 4.5 hours of time using the Boezaart grading system.
Intraoperative Blood loss	Intraoperative blood loss at completion of surgery	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost Effectiveness between TIVA and TXA	Comparison of cost of medications used for the TIVA arm to the arm with general anesthetics and TXA will be determined.	Analysis Within 1 year of the procedure

Collaborators and Investigators

• Sponsor: Our Lady of the Lake Hospital
• Collaborators: Louisiana State University Health Sciences Center in New Orleans
• Investigators: Principal Investigator: Stephen Hernandez, MD, LSU Health Sciences Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Nervous System Malformations; Hernia; Neural Tube Defects; Encephalocele; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Fibrin Modulating Agents; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Antifibrinolytic Agents; Hemostatics; Coagulants; Anesthetics, Inhalation; Anesthetics; Remifentanil; Propofol; Tranexamic Acid; Isoflurane
• Other Study ID Numbers: TIVA vs TXA in Sinus Surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No