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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05639686
Enrollment
100
Registered
2022-12-06
Start date
2023-01-01
Completion date
2025-07-01
Last updated
2023-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Encephalocele, Rhinosinusitis Chronic, Sinus Cancer, Sinus Polyp

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.

Interventions

DRUGTranexamic acid injection

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

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

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 model description

Double Blind, Randomized Cohort

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Surgical Field QualityField quality measured Every 30 minutes over 4.5 hours of time using the Boezaart grading system.Surgical field quality during surgery
Intraoperative Blood lossMeasured once at the conclusion of surgery by measuring the total amount of fluid in the suction canisters minus the total amount of irrigation usedIntraoperative blood loss at completion of surgery

Secondary

MeasureTime frameDescription
Cost Effectiveness between TIVA and TXAAnalysis Within 1 year of the procedureComparison of cost of medications used for the TIVA arm to the arm with general anesthetics and TXA will be determined.

Countries

United States

Contacts

Primary ContactChristine LeBoeuf, DNP
christine.leboeuf@fmolhs.org225-765-5956
Backup ContactLeslie S Son, PhD
Lson@lsuhsc.edu225-757-4165

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026