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NCT Number: NCT06725732

Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Main building, Assiut University Hospitals

Asyut, Egypt

Location status: Recruiting

Location contact

Asmaa Shabaan

CONTACT

[email protected]

+201029505921

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Either sex
  • age 18-65 years
  • ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia
  • 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

Treatment and study plan

Tranexamic acid (TXA)

Drug

To see if nebulised TXA is better to control blood loss in functional Endoscopic sinus surgery

Tranexamic Acid

Drug

To see if intravenous TXA is better to control blood loss in functional Endoscopic sinus surgery

Primary outcomes

  1. Modena Bleeding Score- assessing surgical field

    Time frame: Baseline

    • No bleeding ->1.
    • Bleeding easily controlled by suctioning, washing, or packing without any significant modification or slowing of surgical procedure->2.
    • Bleeding slowing surgical procedure->3.
    • Most of the maneuvers dedicated to bleeding control ->4.
    • Bleeding that prevents every surgical procedure except those dedicated to bleeding control->5.

Secondary outcomes

  1. Measuring patient's Blood Pressure-> mmhg (unit of measure)

    Time frame: Baseline

  2. Measuring patient's Respiratory Rate-> breath per minute(unit of measure)

    Time frame: Baseline

  3. Measuring patient's Temperature-> Celsius(unit of measure)

    Time frame: Baseline

  4. Measuring patient's Pulse->Beat per minute(unit of measure)

    Time frame: Baseline

  5. Measuring End-tidal Co2 by Capnogram

    Time frame: Baseline

    Unit of measure-> mmhg

  6. Measuring O2 saturation by the pulse-oximeter

    Time frame: Baseline

  7. Measuring amount of intraoperative bleeding through blood volume in suction jar

    Time frame: Baseline

  8. Measuring the amount of intraoperative bleeding by counting gauze used in the operation.

    Time frame: Baseline

  9. 2. Anesthetic consumption, Extra doses of fentanyl and propofol and sevoflurane>2

    Time frame: Baseline

  10. Presence or absence of nausea as a Postoperative complication

    Time frame: Baseline

  11. Presence or absence of vomiting as a Postoperative complication

    Time frame: Baseline

  12. Presence or absence of any form of visual disturbance as a Postoperative complication

    Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Asmaa Shabaan Zanaty, Doctor

CONTACT

[email protected]

+201029505921

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score. A Randomized Double Blinded Controlled Trial.

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 10, 2024
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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