Tranexamic Acid Versus Epinephrine During Exploratory Tympanotomy

Assiut University

Status: Completed

Conditions: Intraoperative Bleeding

Treatments: Drug: Epinephrine; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04188184

17300198

Details and patient eligibility

About

Exploratory tympanotomy is surgical access to the middle ear, made for diagnosis and management of unexplained conductive hearing loss, performed under an oto-microscope across the external auditory canal after tympanic membrane elevation to explore the middle ear structures

Full description

Epinephrine is a vasoconstrictor searched intensively for ptimization of the surgical field during microscopic ear and sinus surgeries with controversial results given the possible cardiovascular complication in case of systemic absorption,especially in vulnerable cardiac patients.Tranexamic acid (TXA) as an antifibrinolytic medication is used to treat or prevent excessive bleeding in significant trauma, surgery, tooth removal, or nasal bleeding, discovered by Japanese researchers. TXA, given either oral or intravenous, is a derivative of lysine amino acid; it acts reversibly on the lysine binding sites to block it on the plasminogen molecules. TXA consequently hinders the stimulation of plasminogen competitively, thus reduces its conversion into plasmin. Plasminogen is the enzyme that leads to the degradation of a fibrin clot, fibrinogen, and other plasma proteins, such as factors V and VIII. More than 95% of TXA intravenous administered dose eliminated unchanged through the urinary system. Twenty-four hours after intravenous administration of TXA has demonstrated accumulative excretion of approximately 90%, whereas only 3% is bound to plasminogen. TXA is minimally excreted in breast milk while it can freely cross the blood brain barrier and the placenta .

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 - 60 years old
• ASA (I and II)
• Hb level > 10 mg/dl
• elective ear exploratory tympanotomy surgery under general anesthesia.

Exclusion criteria

• Allergy to TXA
• bleeding/coagulation disorders
• psychiatric illness
• acute and chronic renal failure
• heparin use within 48 hrs or aspirin use within seven days before surgery,
• pregnancy
• liver cirrhosis
• color blindness
• cardiac stent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

tranexmic acid

Active Comparator group

Description:

received topical 1 gram of TXA diluted in 200 ml of normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.

Treatment:

Drug: Tranexamic Acid

Epinephrine roup

Active Comparator group

Description:

received Epinephrine 1 mg diluted in 200 ml normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.

Treatment:

Drug: Epinephrine