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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the idea that TIVA vs TXA in Endoscopic Sinus Surgery is an effective treatment?

The available research shows that Total Intravenous Anesthesia (TIVA) may lead to less bleeding and better visibility during endoscopic sinus surgery compared to inhalational anesthesia. Several studies and meta-analyses suggest that TIVA could improve the surgical field, which is important for the success of the surgery. However, it is noted that TIVA is not used as often as inhalational anesthesia in these surgeries, despite the potential benefits. ^{1 2 3 4 5}

What safety data exists for TIVA vs TXA in endoscopic sinus surgery?

The provided research primarily focuses on comparing total intravenous anesthesia (TIVA) with inhalational anesthesia (IA) in endoscopic sinus surgery, particularly regarding recovery quality, intraoperative blood loss, and surgical field visibility. However, it does not specifically address the safety data for TIVA versus tranexamic acid (TXA) in this context. Further research specifically evaluating the safety of TXA in endoscopic sinus surgery would be needed to answer this question comprehensively. ^{1 2 3 5 6}

Is Total Intravenous Anesthesia (TIVA) a promising treatment compared to inhalational isoflurane for endoscopic sinus surgery?

Yes, Total Intravenous Anesthesia (TIVA) is promising for endoscopic sinus surgery because it may reduce bleeding and improve the visibility of the surgical area, which are important for successful surgery. ^{1 2 3 4 5}

Research Team

Stephen Hernandez, MD

Principal Investigator

LSU Health Sciences Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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) 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Evaluating the Role of Anesthesia on Intraoperative Blood Loss and Visibility during Endoscopic Sinus Surgery: A Meta-analysis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Total intravenous versus inhalational anesthesia in endoscopic sinus surgery: A meta-analysis. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Survey of anesthesiologists on anesthetic maintenance techniques and total intravenous anesthesia for endoscopic sinus surgery. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of total intravenous anesthesia and endoscopic sinus surgery. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Quality of recovery in patients undergoing endoscopic sinus surgery after general anesthesia: total intravenous anesthesia vs desflurane anesthesia. [2020]