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

Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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).

Locations
United States
Louisiana
Our Lady of the Lake Hospital
RECRUITING
Baton Rouge
Contact Information
Primary
Christine LeBoeuf, DNP
christine.leboeuf@fmolhs.org
225-765-5956
Backup
Leslie S Son, PhD
Lson@lsuhsc.edu
225-757-4165
Time Frame
Start Date: 2023-01-01
Completion Date: 2025-07-01
Participants
Target number of participants: 100
Treatments
Placebo_comparator: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Our Lady of the Lake Hospital
Collaborators: Louisiana State University Health Sciences Center in New Orleans

This content was sourced from clinicaltrials.gov

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