An interventional study of Tranexamic acid injection and Total Intravenous Anesthesia in Rhinosinusitis Chronic, Sinus Cancer and Sinus Polyp, sponsored by Our Lady of the Lake Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by Our Lady of the Lake Hospital · Not applicable, Interventional, and Prevention
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:
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.
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.
330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 227 interventional studies indexed under Rhinosinusitis.
Browse Rhinosinusitis studies →Our Lady of the Lake Hospital is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Total Intravenous 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.
Drug: Tranexamic acid injection · Drug: Inhalational isoflurane
Within 10 minutes of general anesthetic induction, 15mg/kg TXA suspended in 100mL of normal saline will be administered intravenously.
Also known as: tranexamic acid (TXA)
Within 10 minutes of induction, patients in the control (TIVA) group will be administered a 100mL bolus of normal saline as placebo.
Also known as: total intravenous anesthesia (propofol, remifentanil)
Inhalational isoflurane or sevoflurane will be administered as a general anesthetic at the induction of the surgical procedure.
Also known as: Inhalational anesthesia
Surgical Field Quality
Surgical field quality during surgery
Time frame: Field quality measured Every 30 minutes over 4.5 hours of time using the Boezaart grading system.
Intraoperative Blood loss
Intraoperative blood loss at completion of surgery
Time frame: 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
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.
Time frame: Analysis Within 1 year of the procedure
Plan to share: No
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