Tranexamic Acid in Functional Endoscopic Sinus Surgery

Ain Shams University159 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

159

Conditions

Anesthesia

Interventions

Oral tranexamic acidDRUG

4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.

Intravenous tranexamic acidDRUG

15mg/kg of tranexamic acid in a 20ml syringe slowly intravenous during induction.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

faculty of medicine, Ain Shams University

Cairo, Egypt

Outcomes

Primary Outcomes

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)

Time frame: At 30 minutes after surgery start

Secondary Outcomes

Incidence of the common adverse effects

Postoperative nasal bleeding, nausea, and vomiting.

Time frame: At 24 hours

Post operative D-dimer

Time frame: At 24 hours

Data from ClinicalTrials.gov

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