drugset / Trial / NCT03965767

Does The Combined Use Of Local And Intravenous Tranexamic Acid Offer Better Surgical Field Quality During Functional Endoscopic Sinus Surgery? A Placebo-Controlled Clinical Trial

NCT03965767

Phase 3 Unknown 120 enrolled Ain Shams University
RandomizedParallel-groupTriple-blindTreatment

Summary

Functional Endoscopic Sinus surgery (FESS) is a surgery done for chronic rhinosinusitis after failure of medical treatment. Intraoperative bleeding poses a challenge to both the surgeon and anaesthetist. Although blood loss is not massive during FESS, bleeding may obscure the surgical field prolonging the time of surgery or even leading to incompletion of the surgery. Different methods have been used to improve the surgical field but none without side effects. The use of diathermy carries the risk of local tissue damage with the risk of subsequent bleeding. Local vasoconstrictors carry the risk of systemic absorption. Induced hypotension may not be suitable for all patients; besides, this may necessitates the use of more anaestheic drugs with their associated side effects. In addition, none of theses methods have provided ideal surgical field for the surgeon.1-3 Tranexamic acid, an antifibrinolytic agent, has been used to decrease surgical field bleeding in different surgeries showing effectiveness in its topical, oral and intravenous use.4-6 The aim of this study is to evaluate the effectiveness of local, intravenous and combined use of tranexamic acid in improving the surgical field quality during functional endoscopic sinus surgery.

Timeline

Start
2019-04-25
Primary completion
2019-08-25
Completion
2019-09-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tranexamic Acid Small molecule 15 mg/kg Intravenous
Comparator Tranexamic Acid Small molecule 2 g Intravenous