Tranexamic Acid in Functional Endoscopic Sinus Surgery

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: Oral tranexamic acid; Drug: Intravenous tranexamic acid

• Registration Number: NCT05686005
• Lead Sponsor: Ain Shams University

Brief Summary

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

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 Timeline

• Study Start: 2022-12-03
• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-06
• Study First Posted: 2023-01-17
• Primary Completion: 2023-04-29
• Study Completion: 2023-04-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral tranexamic	Oral tranexamic acid	The participants will receive 4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.
Intravenous tranexamic	Intravenous tranexamic acid	The participants will receive 15 mg/kg in a 20ml syringe slowly tranexamic acid during induction.

Primary Outcome Measures

Name	Time	Method
Intraoperative field bleeding	At 30 minutes after surgery start	The Wormald grading system for bleeding during endoscopic sinus surgery (0= no bleeding and 10= severe bleeding with sphenoid fills \< 10 seconds)

Secondary Outcome Measures

Name	Time	Method
Incidence of the common adverse effects	At 24 hours	Postoperative nasal bleeding, nausea, and vomiting.
Post operative D-dimer	At 24 hours

Trial Locations

Locations (1)

faculty of medicine, Ain Shams University; 🇪🇬 Cairo, Egypt