Clinical trial NCT06725732: Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score
Official title: Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score. a Randomized Double Blinded Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Blood Loss, Surgical
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to investigate the effect of preoperative administration of intravenous or nebulized tranexamic acid on surgical field, blood loss, anesthetic consumption and hemodynamics of patients undergoing FESS.

Primary outcome Modena Bleeding Score (MBS) assessing surgical field Secondary outcome

1. Patient hemodynamics.
2. Anesthetic consumption, Extra doses of fentanyl and propofol and sevoflurane\>2
3. Postoperative complications: including any adverse effects to TXA e.g.nausea, vomiting, any visual disturbances, fits, and any thrombotic manifestation.

Detailed description: Functional endoscopic sinus surgery (FESS) is the current standard treatment for a variety of conditions affecting the nasal cavity and the paranasal sinuses, such as chronic rhinosinusitis, benign and malignant tumors or cerebrospinal fluid leaks .Being mostly a one-handed technique, FESS does not allow simultaneous use of operative instruments and blood suction, thus endonasal bleeding control represents a challenging issue for the operating surgeon. Such narrow and highly vascularized cavities like the nasal fossae and paranasal spaces can be entirely filled with blood within few seconds, especially if the mucosa is severely inflamed as a consequence of rhinosinusitis. Bleeding is possibly the most relevant factor that could impair the quality of the surgical field during endoscopic procedures. It has been proven that uncontrolled bleeding during endoscopic sinus surgical procedures determines poor visualization of the anatomical landmarks, prolongs surgical time and carries a higher rate of complications .Several techniques to control intraoperative bleeding and improve surgical view during sinus surgery (e.g. topical vasoconstrictors, total intravenous anesthesia, controlled hypotension) have been described and analyzed to determine their efficacy .These types of studies, however, are complex and prone to bias, partially because standardized and validated methods of quantifying bleeding or grading the surgical field in endoscopic view are lacking.

Tranexamic acid functions as the competitive antagonist at the lysine site on plasminogen . During all surgical procedures, the tissue plasminogen activator is released due to tissue damage during surgery, which can convert tissue plasminogen to plasmin, promote fibrinolysis and activate the fibrinolytic system. Thus, tranexamic acid functions as an anti-fibrinolytic agent by inhibiting the tissue plasminogen activator. It can be applied topically or systemically with this mechanism in the coagulation cascade to reduce intraoperative bleeding .The results of several recent studies on endoscopic sinus surgery through topical administration of tranexamic acid are encouraging in terms of the efficacy of tranexamic acid for intraoperative bleeding and other pathological conditions .The purpose of this study is to analyze the efficacy of nebulized tranexamic acid and compare it with intravenous tranexamic acid to improve the surgeon and patient experiences of sinus surgery.

Eligibility criteria: Inclusion Criteria:

1. Either sex
2. age 18-65 years
3. ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia
4. normal accepted coagulation profile and hematocrit value ≥30

Exclusion Criteria:

* • chronic renal failure

  * liver cirrhosis
  * bleeding disorders
  * current anticoagulant therapy
  * pregnancy or breastfeeding
  * impaired color vision
  * severe vascular ischemia
  * history of venous thrombosis, pulmonary embolism
  * long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before surgery
  * hemoglobin (HB) concentration \<10 mg/dl _allergy to TXA.
  * BMI \> 35 kg/ m2

Primary outcomes:
measure: Modena Bleeding Score- assessing surgical field
timeFrame: Baseline
Secondary outcomes:
measure: Measuring patient's Blood Pressure-> mmhg (unit of measure)
timeFrame: Baseline
measure: Measuring patient's Respiratory Rate-> breath per minute(unit of measure)
timeFrame: Baseline
measure: Measuring patient's Temperature-> Celsius(unit of measure)
timeFrame: Baseline
measure: Measuring patient's Pulse->Beat per minute(unit of measure)
timeFrame: Baseline
measure: Measuring End-tidal Co2 by Capnogram
timeFrame: Baseline
measure: Measuring O2 saturation by the pulse-oximeter
timeFrame: Baseline
measure: Measuring amount of intraoperative bleeding through blood volume in suction jar
timeFrame: Baseline
measure: Measuring the amount of intraoperative bleeding by counting gauze used in the operation.
timeFrame: Baseline
measure: 2. Anesthetic consumption, Extra doses of fentanyl and propofol and sevoflurane>2
timeFrame: Baseline
measure: Presence or absence of nausea as a Postoperative complication
timeFrame: Baseline
measure: Presence or absence of vomiting as a Postoperative complication
timeFrame: Baseline
measure: Presence or absence of any form of visual disturbance as a Postoperative complication
timeFrame: Baseline
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Main building, Assiut University Hospitals
Study officials:
References:
citation: Kang H, Hwang SH. Does topical application of tranexamic acid reduce intraoperative bleeding in sinus surgery during general anesthesia? Braz J Otorhinolaryngol. 2020 Jan-Feb;86(1):111-118. doi: 10.1016/j.bjorl.2019.08.006. Epub 2019 Oct 3.
citation: Khosla AJ, Pernas FG, Maeso PA. Meta-analysis and literature review of techniques to achieve hemostasis in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Jun;3(6):482-7. doi: 10.1002/alr.21126. Epub 2012 Dec 16.
citation: Kim DH, Kim S, Kang H, Jin HJ, Hwang SH. Efficacy of tranexamic acid on operative bleeding in endoscopic sinus surgery: A meta-analysis and systematic review. Laryngoscope. 2019 Apr;129(4):800-807. doi: 10.1002/lary.27766. Epub 2018 Dec 28.
citation: Alicandri-Ciufelli M, Pingani L, Mariano D, Anschuetz L, Molinari G, Marchioni D, Bonali M, Galeazzi GM, Presutti L. Rating surgical field quality in endoscopic ear surgery: proposal and validation of the "Modena Bleeding Score". Eur Arch Otorhinolaryngol. 2019 Feb;276(2):383-388. doi: 10.1007/s00405-018-05268-6. Epub 2019 Jan 2.