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TIVA vs TXA in Endoscopic Sinus Surgery
N/A
Recruiting
Led By Stephen Hernandez, MD
Research Sponsored by Our Lady of the Lake Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up analysis within 1 year of the procedure
Awards & highlights
Study Summary
This trial aims to compare the efficacy & cost of TIVA vs TXA + inhalational anesthetics for endoscopic sinus surgery.
Who is the study for?
Adults over 18 who need endoscopic sinus surgery for conditions like chronic rhinosinusitis, sinonasal tumors, or encephalocele repairs at Our Lady of the Lake Regional Medical Center. Not for those under 18, with bleeding disorders, on anticoagulants, thrombosis risk, kidney disease, or TXA allergy.Check my eligibility
What is being tested?
The study compares two anesthesia methods during sinus surgery: TIVA alone versus general inhalational anesthetics with intravenous TXA. It looks at which provides a better surgical view and less blood loss while also considering cost-effectiveness.See study design
What are the potential side effects?
Possible side effects include reactions to anesthesia such as nausea and vomiting post-surgery. Tranexamic acid may cause mild pain at injection site or increase clotting risks in susceptible individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ analysis within 1 year of the procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~analysis within 1 year of the procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intraoperative Blood loss
Surgical Field Quality
Secondary outcome measures
Cost Effectiveness between TIVA and TXA
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transexemic Acid (TXA) and Inhalational AnesthesiaExperimental Treatment2 Interventions
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.
Group II: Total Intravenous Anesthesia (TIVA)Placebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid injection
2021
Completed Phase 4
~3060
Find a Location
Who is running the clinical trial?
Our Lady of the Lake HospitalLead Sponsor
12 Previous Clinical Trials
739 Total Patients Enrolled
Louisiana State University Health Sciences Center in New OrleansOTHER
114 Previous Clinical Trials
43,903 Total Patients Enrolled
Stephen Hernandez, MDPrincipal InvestigatorLSU Health Sciences Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of bleeding or blood clotting issues.I have a history of chronic kidney disease.I have had blood clots in the past.I am under 18 years old.I am currently on blood thinners.I have a condition that increases my risk of blood clots.I am an adult scheduled for sinus surgery at Our Lady of the Lake Regional Medical Center.I am having sinus surgery for conditions like chronic sinusitis or nasal tumors.I have had sinus surgery, either a full or partial procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Total Intravenous Anesthesia (TIVA)
- Group 2: Transexemic Acid (TXA) and Inhalational Anesthesia
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities presently open to join this research?
"Affirmative. Data from clinicaltrials.gov suggests that this medical investigation is presently recruiting patients, which began on January 1st 2023 and was most recently updated on March 21st 2023. The research project requires 100 participants to be recruited across a single site."
Answered by AI
What is the overall enrollment of individuals for this investigation?
"Affirmative. According to the clinicaltrials.gov, this trial is open for enrolment and was first posted on January 1st 2023 with its last update being made on March 21st of that same year. One hundred individuals across a single site are needed for participation in the study."
Answered by AI
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