Rhinosinusitis ChronicNCT05639686
TIVA vs TXA in Sinus Surgery to Evaluate Operative Blood Loss and Surgical Field Quality
A study testing Tranexamic acid injection, Total Intravenous Anesthesia and Inhalational isoflurane in people with Rhinosinusitis Chronic and Sinus Cancer, run by Our Lady of the Lake Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rhinosinusitis Chronic, Sinus Cancer, Sinus Polyp
- What is being tested?
- Tranexamic acid injection, Total Intravenous Anesthesia and Inhalational isoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults (age ≥18 years)
- will undergo endoscopic sinus surgery at Our Lady of the Lake Regional Medical Center
- includes patients who are undergoing endoscopic sinus surgery for myriad of indications, such as chronic rhinosinusitis, sinonasal tumors, and encephalocele repairs.
- includes patients who undergo both complete functional endoscopic sinus surgery, or FESS (i.e maxillary antrostomy, sphenoethmoidectomy, and frontal sinusotomy), as well as those who are undergoing limited functional endoscopic sinus surgeries (i.e. anything less than a complete FESS).
Who cannot join
- <18 years of age
- history of bleeding or coagulation disorder
- currently receiving anticoagulation therapy
- underlying condition with increased risk of thrombosis (e.g. antiphospholipid syndrome),
- history of thromboembolic disorder
- history of chronic kidney disease
- known allergy to tranexamic acid
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, 70808
Leslie Son, Ph.D., 225-757-4165, lson@lsuhsc.edu
Christine LeBoeuf, DNP, 225-765-5956, christine.leboeuf@fmolhs.org
About this study
Official title: Comparison of Inhalational Anesthesia With Intravenous Tranexamic Acid and Total Intravenous Anesthesia on Surgical Field Quality in Endoscopic Sinus Surgery
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Rhinosinusitis Chronic, Sinus Cancer, Sinus Polyp, Encephalocele
- Being tested
- Tranexamic acid injection, Total Intravenous Anesthesia, Inhalational isoflurane
- Medical subject headings
- Encephalocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
Also called tranexamic acid (TXA)
Within 10 minutes of general anesthetic induction, 15mg/kg TXA suspended in 100mL of normal saline will be administered intravenously.
Total Intravenous AnesthesiaDrug
Also called total intravenous anesthesia (propofol, remifentanil)
Within 10 minutes of induction, patients in the control (TIVA) group will be administered a 100mL bolus of normal saline as placebo.
Inhalational isofluraneDrug
Also called Inhalational anesthesia
Inhalational isoflurane or sevoflurane will be administered as a general anesthetic at the induction of the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Total Intravenous Anesthesia (TIVA) | Placebo comparator | 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. Receives: Drug: Total Intravenous Anesthesia |
| Transexemic Acid (TXA) and Inhalational Anesthesia | Experimental | 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. Receives: Drug: Tranexamic acid injection; Drug: Inhalational isoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Field Quality
Surgical field quality during surgery
Measured: 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
Measured: 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
Secondary outcomes (1)
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.
Measured: Analysis Within 1 year of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinosinusitis ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Blind, Randomized Cohort
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Our Lady of the Lake Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Responsible party
- Principal investigator, Leslie Son, Our Lady of the Lake Hospital
- Investigators
- Stephen Hernandez, MD, Principal investigator, LSU Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639686
- Sponsor's protocol ID
- TIVA vs TXA in Sinus Surgery
- Status last verified
- Mar 2023
- First submitted
- 14 Nov 2022
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inhalational Anesthesia With Intravenous Tranexamic Acid and Total Intravenous Anesthesia on Surgical Field Quality in Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT05639686
- Acronym / sponsor ID
- TIVA vs TXA in Sinus Surgery
- Conditions
- Rhinosinusitis Chronic, Sinus Cancer, Sinus Polyp, Encephalocele
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Our Lady of the Lake HospitalUniversity, hospital or other
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Double Blind, Randomized Cohort
| Arm | Type | Receives |
|---|---|---|
| Total Intravenous Anesthesia (TIVA) | Placebo comparator | Drug: Total Intravenous AnesthesiaPatients 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. |
| Transexemic Acid (TXA) and Inhalational Anesthesia | Experimental | Drug: Tranexamic acid injection, Drug: Inhalational isofluranePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults (age ≥18 years)
- will undergo endoscopic sinus surgery at Our Lady of the Lake Regional Medical Center
- includes patients who are undergoing endoscopic sinus surgery for myriad of indications, such as chronic rhinosinusitis, sinonasal tumors, and encephalocele repairs.
- includes patients who undergo both complete functional endoscopic sinus surgery, or FESS (i.e maxillary antrostomy, sphenoethmoidectomy, and frontal sinusotomy), as well as those who are undergoing limited functional endoscopic sinus surgeries (i.e. anything less than a complete FESS).
Key exclusion criteria (7 listed)
- <18 years of age
- history of bleeding or coagulation disorder
- currently receiving anticoagulation therapy
- underlying condition with increased risk of thrombosis (e.g. antiphospholipid syndrome),
- history of thromboembolic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid injectionAlso: tranexamic acid (TXA)Within 10 minutes of general anesthetic induction, 15mg/kg TXA suspended in 100mL of normal saline will be administered intravenously. | Drug | Transexemic Acid (TXA) and Inhalational Anesthesia |
| Total Intravenous AnesthesiaAlso: total intravenous anesthesia (propofol, remifentanil)Within 10 minutes of induction, patients in the control (TIVA) group will be administered a 100mL bolus of normal saline as placebo. | Drug | Total Intravenous Anesthesia (TIVA) |
| Inhalational isofluraneAlso: Inhalational anesthesiaInhalational isoflurane or sevoflurane will be administered as a general anesthetic at the induction of the surgical procedure. | Drug | Transexemic Acid (TXA) and Inhalational Anesthesia |
Primary outcome
Surgical Field Quality
Time frame: Field quality measured Every 30 minutes over 4.5 hours of time using the Boezaart grading system.
Surgical field quality during surgery
Intraoperative Blood loss
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
Intraoperative blood loss at completion of surgery
1 secondary outcome
Cost Effectiveness between TIVA and TXA
Time frame: Analysis Within 1 year of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Rhinosinusitis Chronic
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Hernandez, MD principal investigator
LSU Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid injection, Total Intravenous Anesthesia and Inhalational isoflurane in people with Rhinosinusitis Chronic and Sinus Cancer, run by Our Lady of the Lake Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine LeBoeuf, DNP (225-765-5956, christine.leboeuf@fmolhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Field Quality (time frame: Field quality measured Every 30 minutes over 4.5 hours of time using the Boezaart grading system.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.