Nebulized Tranexamic Acid in Sinus Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bleeding Nose
• Intervention / Treatment: Drug: Tranexamic acid; Other: Saline placebo

Detailed Description

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)

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Assuit
    • Asyut, Assuit, Egypt, Assuit universi
      • Recruiting
      • Assuit
      • Contact: Omar Soliman; Phone Number: 01101266040; Email: omarmakram347@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic acid 500 mg; Nebulized tranexamic acid 500 mg 15 minutes before operation	Drug: Tranexamic acid; Tranexamic acid nebulization 15 minutes before sinus surgery; Other Names: Cyclokapron
Experimental: Tranexamic acid 1gm; Nebulized tranexamic acid 1 gm 15 minutes before operation	Drug: Tranexamic acid; Tranexamic acid nebulization 15 minutes before sinus surgery; Other Names: Cyclokapron
Placebo Comparator: Saline placebo; Normal saline nebulization 15 minutes before operation	Other: Saline placebo; Normal saline placebo nebulization 15 minutes before sinus surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Modena Bleeding Score (MBS) assessing surgical field	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	After anesthesia induction to 60 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HR	Heart rate beat/min	Intraoperative duration
MBP	Mean blood pressure mmHg	Intraoperative duration
Anesthetic consumption	Extra doses of fentanyl and propofol and sevoflurane>2	Anesthesia duration
Postoperative complications	Recording any adverse effects to TXA e.g.nausea, vomiting and any visual disturbances	After operation to 24 hour

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Estimated): April 5, 2026
• Study Completion (Estimated): April 10, 2026

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Hemorrhage; Nose Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Epistaxis; Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid
• Other Study ID Numbers: 17300595

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No