Tranexamic Acid Versus Epinephrine During Exploratory Tympanotomy

Study Overview
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Brief Summary
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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

Detailed Description
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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 .

Official Title
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Topical Use of Tranexamic Acid Versus Epinephrine to Optimize Surgical Field During Exploratory Tympanotomy

Conditions
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Intraoperative Bleeding

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Epinephrine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tranexmic acid<br>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. | Drug: Tranexamic Acid<br>* 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.<br>|
| Active Comparator: Epinephrine roup<br>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. | Drug: Epinephrine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State of surgical field categorized by surgeons based on Boezaart classification | Grade Description 0 No bleeding (cadaveric conditions) Slight bleeding: no suctioning required Slight bleeding: occasional suctioning required Slight bleeding: frequent suctioning required, bleeding threatens surgical field a few seconds after suction is removed Moderate bleeding: frequent suctioning required and bleeding threatens surgical field directly after suction is removed Severe bleeding: constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible | 2 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding volume | The quantity of blood (ml) = (mass of used + fresh gauze - weight of all sponges before surgery) / 1.05. | 2 hour |