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NCT Number: NCT04905901

Nebulized Tranexamic Acid in Sinus Surgery

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 to improve the surgeon and patient experiences of sinus surgery and know the effective and safe dose of nebulized tranexamic acid.

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Key information

Conditions

Bleeding Nose Epistaxis Hemorrhage Nose Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assuit

Asyut, Assuit, Assuit universi, Egypt

About this study

A written informed consent will be taken from the patients.The study involved adults of either sexes (age 18-65 years) of ASA I-II who will be listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia, with normal accepted coagulation profile and hematocrit value ≥30 %. Excluded from the study patients with 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, a hemoglobin (HB) concentration <10 mg/dl or allergy to TXA.

Randomization: A random number sequence created by an internet website (http://www. random.org) will be used for patients' allocation. The random number sequence was retained in closed opaque envelopes released the day of the surgery by an independent physician not involved in the study. Patients will be assigned randomly to three groups (30 subjects each); saline placebo (Group S) and two different doses of preemptive nebulized tranexamic acid (Group T1) and (Group T2).To keep blinding, Group S will receive 2 sessions of nebulization each by 5 ml saline. Group T1 will receive one nebulization session 500 mg tranexamic acid (5 ml) and another one by 5 ml saline. Group T2 will receive 2 nebulization sessions each by 500 mg tranexamic acid (each by 5 ml)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Either sexes (age 18-65 years) of 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.

Treatment and study plan

Tranexamic Acid

Drug

Tranexamic acid nebulization 15 minutes before sinus surgery

Other names: Cyclokapron

Saline Placebo

Other

Normal saline placebo nebulization 15 minutes before sinus surgery

Primary outcomes

  1. the Modena Bleeding Score (MBS) assessing surgical field

    Time frame: After anesthesia induction to 60 minute

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

Secondary outcomes

  1. HR

    Time frame: Intraoperative duration

    Heart rate beat/min

  2. MBP

    Time frame: Intraoperative duration

    Mean blood pressure mmHg

  3. Anesthetic consumption

    Time frame: Anesthesia duration

    Extra doses of fentanyl and propofol and sevoflurane>2

  4. Postoperative complications

    Time frame: After operation to 24 hour

    Recording any adverse effects to TXA e.g.nausea, vomiting and any visual disturbances

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Does Nebulized Tranexamic Acid Affect Operative Field in Sinus Surgery? A Double Blind Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 28, 2021
Registry last updated
Jun 16, 2026

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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