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

NCT05639686 | Unknown

• 1 other identifier: TIVA vs TXA in Sinus Surgery
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Cost Effectiveness between TIVA and TXA

  Analysis Within 1 year of the procedure

Study Arms (2)

Total Intravenous Anesthesia (TIVA)

PLACEBO COMPARATOR

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

Transexemic Acid (TXA) and Inhalational Anesthesia

EXPERIMENTAL

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; Drug: Inhalational isoflurane

Interventions

Tranexamic acid injection DRUG

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

Also known as: tranexamic acid (TXA)

Transexemic Acid (TXA) and Inhalational Anesthesia

Total Intravenous Anesthesia DRUG

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

Also known as: total intravenous anesthesia (propofol, remifentanil)

Total Intravenous Anesthesia (TIVA)

Inhalational isoflurane DRUG

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

Also known as: Inhalational anesthesia

Transexemic Acid (TXA) and Inhalational Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \<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

Sponsors & Collaborators

• Our Lady of the Lake Hospital: lead
• Louisiana State University Health Sciences Center in New Orleans: collaborator

Study Sites (1)

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, 70808, United States

RECRUITING

MeSH Terms

Conditions

Encephalocele

Interventions

Tranexamic Acid; Propofol; Remifentanil

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Propionates; Acids, Acyclic; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stephen Hernandez, MD

  LSU Health Sciences Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine LeBoeuf, DNP

CONTACT

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

Leslie S Son, PhD

CONTACT

225-757-4165; Lson@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The operating surgeon will be blinded to the type of anesthesia used by applying a surgical drape between surgeon and patient and anesthesia team. The patient will also not know which anesthesia arm they will be placed in as the randomization will occur prior to surgery and will only be known to the anesthesia team and other study team members who are not operating on the patient.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: Double Blind, Randomized Cohort

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: December 6, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: July 1, 2025
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)