TIVA vs TXA in Endoscopic Sinus Surgery

Overseen By Leslie S Son, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Our Lady of the Lake Hospital

Must not be taking: Anticoagulants

Disqualifiers: Bleeding disorder, Thrombosis risk, Kidney disease, others

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods of managing anesthesia during endoscopic sinus surgery to determine which provides a clearer surgical field and is more cost-effective. One group will receive total intravenous anesthesia (TIVA), while the other will receive a combination of tranexamic acid (TXA) and inhalational anesthesia with isoflurane. The trial will assess blood loss and surgical field clarity to identify the better option. Individuals scheduled for endoscopic sinus surgery, such as for chronic sinus issues or tumors, may be suitable candidates for this study. As an unphased trial, it offers participants the opportunity to contribute to valuable research that could enhance surgical outcomes.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on anticoagulation therapy, you cannot participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tranexamic acid (TXA) is generally safe for surgeries such as endoscopic sinus surgery. One study found no blood clot issues related to TXA within 28 days post-surgery, with only about 1.3% of patients experiencing minor complications. Another study found that TXA can help reduce blood loss during surgery without increasing the risk of complications.

Total intravenous anesthesia (TIVA) is a common and safe method used in many surgeries. It involves drugs like fentanyl and propofol, which are well-known and widely used in hospitals. Both TXA and TIVA are commonly used and usually well-tolerated, making them safe options for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore innovative approaches to anesthesia in endoscopic sinus surgery. Unlike the standard method of Total Intravenous Anesthesia (TIVA) using propofol and remifentanil, the experimental treatment combines the inhalational agents isoflurane or sevoflurane with tranexamic acid (TXA). TXA is particularly exciting because it has the potential to reduce bleeding during surgery by stabilizing clots, which could lead to improved surgical outcomes and recovery times. This combination of inhalational anesthesia and TXA might offer a new way to enhance patient safety and effectiveness during these complex procedures.

What evidence suggests that this trial's treatments could be effective for endoscopic sinus surgery?

Research has shown that tranexamic acid (TXA) with inhalational anesthesia can significantly reduce blood loss during sinus surgery. Studies have found that TXA helps maintain a clear surgical area, facilitating the surgeon's work and potentially shortening the surgery duration. These advantages occur without increasing the risk of complications. In this trial, one group of participants will receive TXA with inhalational anesthesia. In contrast, total intravenous anesthesia (TIVA), known for providing steady anesthesia, will be administered to another group. This study compares these two methods to determine which one better maintains a clear surgical area and reduces blood loss. ^{1 4 6 7 8}

Who Is on the Research Team?

Stephen Hernandez, MD

Principal Investigator

LSU Health Sciences Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative

Participants are informed about the study and consented during pre-operative clinic visits

1 day

1 visit (in-person)

Treatment

Participants undergo endoscopic sinus surgery with either TIVA or TXA and inhalational anesthesia

1 day

1 visit (in-person)

Follow-up

Participants are monitored for surgical outcomes and cost-effectiveness analysis

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inhalational isoflurane
• Total Intravenous Anesthesia
• Tranexamic acid injection

Trial Overview 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.

How Is the Trial Designed?

Group I: Transexemic Acid (TXA) and Inhalational Anesthesia Experimental Treatment 2 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 Group 1 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.

Inhalational isoflurane is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Isoflurane for:

• Induction and maintenance of general anesthesia

Approved in United States as Isoflurane for:

• Induction and maintenance of general anesthesia

Approved in Canada as Isoflurane for:

• Induction and maintenance of general anesthesia

Approved in Japan as Isoflurane for:

• Induction and maintenance of general anesthesia

Approved in China as Isoflurane for:

• Induction and maintenance of general anesthesia

Approved in Switzerland as Isoflurane for:

• Induction and maintenance of general anesthesia

Who Is Running the Clinical Trial?

Our Lady of the Lake Hospital

Lead Sponsor

Trials

15

Recruited

900+

Louisiana State University Health Sciences Center in New Orleans

Collaborator

Trials

123

Recruited

42,400+

Published Research Related to This Trial

A survey of 200 anesthesia providers revealed that 65% were not familiar with the literature supporting the benefits of total intravenous anesthesia (TIVA) for endoscopic sinus surgery (ESS), which is associated with improved surgical visualization and reduced bleeding.

Despite being comfortable with TIVA, many providers expressed a desire for additional training, indicating a potential opportunity to enhance education and practice regarding anesthetic techniques in ESS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of anesthesiologists on anesthetic maintenance techniques and total intravenous anesthesia for endoscopic sinus surgery. Yoshiyasu, Y., Lao, VF., Schechtman, S., et al.[2021]

Total intravenous anesthesia (TIVA) resulted in significantly lower intraoperative bleeding and better visibility during endoscopic sinus surgery compared to inhalational anesthesia (IA), based on a meta-analysis of 19 randomized controlled trials involving 1,010 patients.

While TIVA showed advantages in terms of bleeding and visibility, the results varied depending on the use of specific anesthetics like remifentanil and desflurane, indicating that no definitive conclusion can be drawn about the superiority of one method over the other.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Role of Anesthesia on Intraoperative Blood Loss and Visibility during Endoscopic Sinus Surgery: A Meta-analysis. Moffatt, DC., McQuitty, RA., Wright, AE., et al.[2021]

Total intravenous anesthesia (TIVA) significantly improves surgical field visibility and reduces blood loss during endoscopic sinus surgery (ESS) compared to inhalational anesthesia (IA), based on a meta-analysis of 15 randomized control trials involving 828 cases.

Despite the advantages of TIVA, the analysis revealed significant heterogeneity, suggesting that further validation is needed before concluding that one anesthesia method is definitively superior to the other.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total intravenous versus inhalational anesthesia in endoscopic sinus surgery: A meta-analysis. Lu, VM., Phan, K., Oh, LJ.[2020]

Total intravenous anesthesia (TIVA) may improve visibility during endoscopic sinus surgery compared to inhalational anesthesia (IA), as indicated by a statistically significant preference for TIVA in visibility scores (p < 0.001) across the limited studies reviewed.

However, there were no significant differences in cardiovascular parameters, anesthesia time, operative time, or estimated blood loss between TIVA and IA, suggesting that both anesthesia methods are similarly safe and effective in these aspects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of total intravenous anesthesia and endoscopic sinus surgery. DeConde, AS., Thompson, CF., Wu, EC., et al.[2018]

Patients undergoing endoscopic sinus surgery who received total intravenous anesthesia (TIVA) reported a significantly better quality of recovery at 6 hours post-surgery compared to those who received desflurane anesthesia, as measured by the QoR-40 questionnaire (188.2 vs 182.6).

TIVA also resulted in significantly less blood loss during surgery, indicating not only a better recovery experience but also a potentially safer surgical procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of recovery in patients undergoing endoscopic sinus surgery after general anesthesia: total intravenous anesthesia vs desflurane anesthesia. Liu, T., Gu, Y., Chen, K., et al.[2020]

Total intravenous anaesthesia (TIVA) with propofol significantly improves surgical visibility, reduces estimated blood loss, and decreases operative time during endoscopic sinus surgery (ESS) compared to inhaled anaesthesia (IA), based on a meta-analysis of 12 randomized controlled trials involving 560 patients.

The use of remifentanil as the short-acting opioid in TIVA enhances these benefits, while using fentanyl does not provide the same advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total intravenous anaesthesia versus inhaled anaesthesia for endoscopic sinus surgery: a meta-analysis of randomized controlled trials. Kolia, NR., Man, LX.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12547610/

Temporal Effects of Tranexamic Acid Administration on ... TXA has been reported to reduce intraoperative blood loss, improve surgical field visibility, and shorten the operative time in both FESS and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11306473/

A Comparison of Tranexamic Acid in Nasal Versus Sinus ... TXA was shown to significantly reduce the amount of blood loss in sinus and nasal surgeries as compared to placebo, regardless of the various routes of ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/11101849.2024.2313414

”The efficacy of oral versus intravenous tranexamic acid in ... Our study aims to evaluate and compare the effectiveness of oral versus intravenous Tranexamic acid on surgical field bleeding in endoscopic sinus surgery.

4. pajr.researchcommons.org pajr.researchcommons.org/cgi/viewcontent.cgi?article=1085&context=journal

Outcomes of large dose Tranexamic acid in endoscopic ... It has a positive impact on reduction of blood loss, operative time and on surgical field quality without increased risk of complications. Keywords: Tranexamic ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2019/04190/role_of_tranexamic_acid_in_nasal_surgery__a.27.aspx

Role of tranexamic acid in nasal surgery The results indicated that the TXA have a positive effect in decrease intraoperative blood loss, improve the surgical field quality, and reducing periorbital ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36808096/

Tranexamic acid for the reduction of bleeding during ... Tranexamic acid may result in a slight reduction in blood loss during surgery compared to placebo with a mean difference (MD) of -70.32 mL.

7. mdpi.com mdpi.com/2673-351X/6/2/8

The Safety of Topical and Intravenous Tranexamic Acid in ... The retrospective study showed no thromboembolic complications attributable to TXA in the 28 days after ESS. Only two patients (1.3%) who ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05686005

Tranexamic Acid in Functional Endoscopic Sinus Surgery The purpose of the study is to compare the effect of oral tranexamic acid vs. intravenous in decreasing bleeding and improving the field during FESS.