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

Rhinosinusitis Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05639686
• Other study ID #: TIVA vs TXA in Sinus Surgery
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: March 2023
• Source: Our Lady of the Lake Hospital
• Contact: Christine LeBoeuf, DNP
• Phone: 225-765-5956
• Email: christine.leboeuf[@]fmolhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Encephalocele
• Rhinosinusitis Chronic

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Our Lady of the Lake Hospital	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Our Lady of the Lake Hospital	Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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