Overview

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

Status:
Unknown status
Trial end date:
2019-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ain Shams University
Treatments:
Tranexamic Acid
Criteria
Inclusion Criteria:

- patients underwent endoscopic sinus surgery

Exclusion Criteria:

- patients with uncontrolled hypertension or coronary artery disease, anaemia, end stage
renal failure, liver cirrhosis, patients with coagulopathy or receiving drugs
influencing blood coagulation, cerebrovascular thrombosis or history of thrombotic
events, pregnancy, known sensitivity to any of the study drug and patients' refusal to
participate in the study.