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

NCT05639686 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-03-23

No results posted yet for this study

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.

Conditions

  • Rhinosinusitis Chronic
  • Sinus Cancer
  • Sinus Polyp
  • Encephalocele

Interventions

DRUG

Tranexamic acid injection

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

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.

DRUG

Inhalational isoflurane

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

Sponsors & Collaborators

  • Louisiana State University Health Sciences Center in New Orleans

    collaborator OTHER

  • Our Lady of the Lake Hospital

    lead OTHER

Principal Investigators

  • Stephen Hernandez, MD · LSU Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-12-31
Completion
2025-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05639686 on ClinicalTrials.gov