Tranexamic Acid in Functional Endoscopic Sinus Surgery

Study Overview
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Brief Summary
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The purpose of the study is to compare the effect of oral tranexamic acid vs. intravenous in decreasing bleeding and improving the field during FESS.

Detailed Description
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The use of tranexamic acid during Intraoperative bleeding in functional endoscopic sinus surgery (FESS) improves the outcome. Bleeding is one of the most devastating complications during fess. Tranexamic acid is used in open heart surgery to improve the surgical field. Using oral vs. intravenous forms of the drug will add to our knowledge and improve outcomes.

Official Title
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The Efficacy of Oral Versus Intravenous Tranexamic Acid in Functional Endoscopic Sinus Surgery. A Prospective, Randomized, Double-blind Controlled Trial.

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Oral tranexamic acid
* Drug: Intravenous tranexamic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists grade I or II. Sex: Both sexes. Age between 18 and 40 years. Patients scheduled for FESS under general anesthesia. Exclusion Criteria: Declining to give written informed consent. History of allergy to the medications used in the study. History of venous or arterial thrombosis. history of cardiovascular diseases including AF, IHD, or hypertension. History of chest problems including pulmonary embolism, bronchial asthma and COPD. History of cerebrovascular stroke. History of drug or alcohol abuse. Taking opioids or sedative medications. Hepatic or renal failure. Bleeding disorders, antiplatelets (aspirin, clopidogrel) or anticoagulant (warfarin).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No intervention | |
| Active Comparator: Oral tranexamic<br>The participants will receive 4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward. | Drug: Oral tranexamic acid<br>* 4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.<br>|
| Active Comparator: Intravenous tranexamic<br>The participants will receive 15 mg/kg in a 20ml syringe slowly tranexamic acid during induction. | Drug: Intravenous tranexamic acid<br>* 15mg/kg of tranexamic acid in a 20ml syringe slowly intravenous during induction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative field bleeding | The Wormald grading system for bleeding during endoscopic sinus surgery (0= no bleeding and 10= severe bleeding with sphenoid fills < 10 seconds) | At 30 minutes after surgery start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of the common adverse effects | Postoperative nasal bleeding, nausea, and vomiting. | At 24 hours | 
| Post operative D-dimer |  | At 24 hours |