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

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

NCT ID: NCT05639686

Condition: Rhinosinusitis Chronic
Sinus Cancer
Sinus Polyp
Encephalocele

Conditions: Official terms:
Rhinosinusitis
Encephalocele
Remifentanil
Anesthetics
Propofol
Isoflurane
Tranexamic Acid

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Double Blind, Randomized Cohort

Primary purpose: Prevention

Masking: Double (Participant, Care Provider)

Masking description: 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.

Intervention:

Intervention type: Drug
Intervention name: Tranexamic acid injection
Description: Within 10 minutes of general anesthetic induction, 15mg/kg TXA suspended in 100mL of normal saline will be administered intravenously.
Arm group label: Transexemic Acid (TXA) and Inhalational Anesthesia

Other name: tranexamic acid (TXA)

Intervention type: Drug
Intervention name: Total Intravenous Anesthesia
Description: Within 10 minutes of induction, patients in the control (TIVA) group will be administered a 100mL bolus of normal saline as placebo.
Arm group label: Total Intravenous Anesthesia (TIVA)

Other name: total intravenous anesthesia (propofol, remifentanil)

Intervention type: Drug
Intervention name: Inhalational isoflurane
Description: Inhalational isoflurane or sevoflurane will be administered as a general anesthetic at the induction of the surgical procedure.
Arm group label: Transexemic Acid (TXA) and Inhalational Anesthesia

Other name: Inhalational anesthesia

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.

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Our Lady of the Lake Hospital

Address:
City: Baton Rouge
Zip: 70808
Country: United States

Status: Recruiting

Contact:
Last name: Leslie Son, Ph.D.

Phone: 225-757-4165
Email: lson@lsuhsc.edu

Contact backup:
Last name: Christine LeBoeuf, DNP

Phone: 225-765-5956
Email: christine.leboeuf@fmolhs.org

Start date: January 1, 2023

Completion date: July 1, 2025

Lead sponsor:
Agency: Our Lady of the Lake Hospital
Agency class: Other

Collaborator:
Agency: Louisiana State University Health Sciences Center in New Orleans
Agency class: Other

Source: Our Lady of the Lake Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05639686