Tranexamic Acid in Functional Endoscopic Sinus Surgery

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Drug: Oral tranexamic acid; Drug: Intravenous tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05686005

FMASU R 237/ 2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 159 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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159 participants in 3 patient groups

Control

No Intervention group

Description:

No intervention

Oral tranexamic

Active Comparator group

Description:

The participants will receive 4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.

Treatment:

Drug: Oral tranexamic acid

Intravenous tranexamic

Active Comparator group

Description:

The participants will receive 15 mg/kg in a 20ml syringe slowly tranexamic acid during induction.

Treatment:

Drug: Intravenous tranexamic acid