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

NCT ID: NCT05639686

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-07-01

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.

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.

Conditions

Rhinosinusitis Chronic; Sinus Cancer; Sinus Polyp; Encephalocele

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Total Intravenous Anesthesia

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Tranexamic acid injection

Intervention Type: DRUG

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

Inhalational isoflurane

Intervention Type: DRUG

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

Interventions

Tranexamic acid injection

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

Intervention Type: 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.

Intervention Type: DRUG

Inhalational isoflurane

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

Intervention Type: DRUG

Other Intervention Names

tranexamic acid (TXA); total intravenous anesthesia (propofol, remifentanil); Inhalational anesthesia

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role: collaborator

Our Lady of the Lake Hospital

OTHER

Sponsor Role: lead

Responsible Party

Leslie Son

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Hernandez, MD

Role: PRINCIPAL_INVESTIGATOR

LSU Health Sciences Center

Locations

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christine LeBoeuf, DNP

Role: CONTACT

christine.leboeuf@fmolhs.org

225-765-5956

Leslie S Son, PhD

Role: CONTACT

Lson@lsuhsc.edu

225-757-4165

Facility Contacts

Leslie Son, Ph.D.

Role: primary

lson@lsuhsc.edu

225-757-4165

Christine LeBoeuf, DNP

Role: backup

christine.leboeuf@fmolhs.org

225-765-5956

Other Identifiers

TIVA vs TXA in Sinus Surgery

Identifier Type: -

Identifier Source: org_study_id