Tranexamic Acid in Functional Endoscopic Sinus Surgery

Anesthesia Clinical Trial

Official title:

The Efficacy of Oral Versus Intravenous Tranexamic Acid in Functional Endoscopic Sinus Surgery. A Prospective, Randomized, Double-blind Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05686005
• Other study ID #: FMASU R 237/ 2022
• Status: Completed
• Phase: Phase 4
• Start date: December 3, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: April 30, 2023
• Est. primary completion date: April 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Oral tranexamic acid
4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.
• Intravenous tranexamic acid
15mg/kg of tranexamic acid in a 20ml syringe slowly intravenous during induction.

Locations

Country	Name	City	State
Egypt	faculty of medicine, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	At 30 minutes after surgery start
Secondary	Incidence of the common adverse effects	Postoperative nasal bleeding, nausea, and vomiting.	At 24 hours
Secondary	Post operative D-dimer		At 24 hours