Comparative Study of Two Different Intravenous Doses of Tranexamic Acid with Placebo on Surgical Field Quality in Functional Endoscopic Sinus Surgery- A Randomised Clinical Trial UC05-UC09
Kodali V Rajesh Kumar,
Flat No. F20, SRMC Staff Quarters, F Block, Porur, Chennai, Tamil Nadu, India.
Introduction: Intraoperative haemorrhage, which disrupts surgical patency, is a major obstacle for surgeons, especially in endoscopic sinus surgeries. Tranexamic acid is synthetic antifibrinolytic agent that binds competitively at lysine binding site on plasminogen prevents fibrinolysis, improves blood clot formation and reduces bleeding. The role of tranexamic acid by topical adminstration during Functional Endoscopic Sinus Surgeries (FESS) had contrasting reports and limited number of studies are available with systemic adminstration of tranexamic acid in FESS surgeries.
Aim: To compare two different intravenous doses of tranexamic acid with placebo on surgical field quality, surgical time and blood loss in FESS surgeries.
Materials and Methods: Eighty four ASA physical status I and II patients from January 2013 to December 2013 aged 18-60 years, who underwent FESS surgery, were included in the study. Patients were randomised to Group A receiving 15 mg.kg-1 tranexamic acid Group B receiving 5 mg.kg-1 tranexamic acid and Group C as placebo receiving normal saline. Heart rate, systolic, diastolic blood pressure, oxygen saturation, blood loss and surgical site quality were recorded. Statistical analysis between treatment groups was performed using repeated measures of ANOVA and intergroup analysis was performed where appropriate. The primary outcome was surgical field quality; secondary outcome was blood loss and surgical time.
Results: Intravenous administration of tranexamic acid was found to reduce the total blood loss in FESS surgery by 64% in group A (15 mg.kg-1) and 31% in group B (5 mg.kg-1) compared to placebo (p=0.0001). Reduction in bleeding by administration of tranexamic acid also led to an improved surgical field quality. There was partial surgical field clearance at a low dose of tranexamic acid while 15 mg.kg-1 of the drug achieved about 100% surgical site clearance as measured with Wormald Grading Scale of surgical field quality (p=0.0001). This was also validated by a surgeon satisfaction score after FESS procedure using Likert scale and the fraction of patients for whom surgery was affected by bleeding. The surgical field improvement by use of tranexamic acid has also been found to have a prominent reduction in the total time taken to complete the surgery. Administration of 5 mg.kg-1 drug led to a 7% reduction and 15 mg.kg-1 of tranexamic acid led to about 15% reduction in time taken for FESS surgery (p=0.0001).
Conclusion: Tranexamic acid 15 mg/kg dose effectively reduces blood loss, improves surgical field quality and reduces surgical time.