Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06725732

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

Led by Assiut University · Updated on 2025-01-29

90

Participants Needed

1

Research Sites

48 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Either sex
  • Age 18-65 years
  • ASA I-II patients listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia
  • Normal coagulation profile and hematocrit value 30
Not Eligible

You will not qualify if you...

  • Chronic renal failure
  • Liver cirrhosis
  • Bleeding disorders
  • Current anticoagulant therapy
  • Pregnancy or breastfeeding
  • Impaired color vision
  • Severe vascular ischemia
  • History of venous thrombosis or pulmonary embolism
  • Long-term treatment with acetylsalicylic acid or NSAIDs not discontinued before surgery
  • Hemoglobin concentration <10 mg/dl
  • Allergy to tranexamic acid
  • Body mass index >35 kg/m2

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Main building, Assiut University Hospitals

Asyut, Egypt

Actively Recruiting

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Research Team

A

Asmaa Shabaan Zanaty, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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