Nebulized Tranexamic Acid in Sinus Surgery

Study Overview
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Brief Summary
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The results of several recent studies on endoscopic sinus surgery through topical administration of tranexamic acid are encouraging in terms of the efficacy of tranexamic acid for intraoperative bleeding and other pathological conditions.The purpose of this study is to analyze the efficacy of nebulized tranexamic acid to improve the surgeon and patient experiences of sinus surgery and know the effective and safe dose of nebulized tranexamic acid.

Detailed Description
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A written informed consent will be taken from the patients.The study involved adults of either sexes (age 18-65 years) of ASA I-II who will be listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia, with normal accepted coagulation profile and hematocrit value ≥30 %. Excluded from the study patients with chronic renal failure, liver cirrhosis, bleeding disorders, current anticoagulant therapy, pregnancy or breastfeeding, impaired color vision, severe vascular ischemia, history of venous thrombosis, pulmonary embolism, long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before surgery, a hemoglobin (HB) concentration <10 mg/dl or allergy to TXA. Randomization: A random number sequence created by an internet website (http://www. random.org) will be used for patients' allocation. The random number sequence was retained in closed opaque envelopes released the day of the surgery by an independent physician not involved in the study. Patients will be assigned randomly to three groups (30 subjects each); saline placebo (Group S) and two different doses of preemptive nebulized tranexamic acid (Group T1) and (Group T2).To keep blinding, Group S will receive 2 sessions of nebulization each by 5 ml saline. Group T1 will receive one nebulization session 500 mg tranexamic acid (5 ml) and another one by 5 ml saline. Group T2 will receive 2 nebulization sessions each by 500 mg tranexamic acid (each by 5 ml)

Official Title
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Does Nebulized Tranexamic Acid Affect Operative Field in Sinus Surgery? A Double Blind Randomized Clinical Trial

Conditions
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Bleeding Nose

Intervention / Treatment
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* Drug: Tranexamic acid
* Other: Saline placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Either sexes (age 18-65 years) of ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia normal accepted coagulation profile and hematocrit value ≥30 Exclusion Criteria: chronic renal failure liver cirrhosis bleeding disorders current anticoagulant therapy pregnancy or breastfeeding impaired color vision severe vascular ischemia history of venous thrombosis, pulmonary embolism long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before surgery hemoglobin (HB) concentration <10 mg/dl _allergy to TXA.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid 500 mg<br>Nebulized tranexamic acid 500 mg 15 minutes before operation | Drug: Tranexamic acid<br>* Tranexamic acid nebulization 15 minutes before sinus surgery<br>* Other names: Cyclokapron;|
| Experimental: Tranexamic acid 1gm<br>Nebulized tranexamic acid 1 gm 15 minutes before operation | Drug: Tranexamic acid<br>* Tranexamic acid nebulization 15 minutes before sinus surgery<br>* Other names: Cyclokapron;|
| Placebo Comparator: Saline placebo<br>Normal saline nebulization 15 minutes before operation | Other: Saline placebo<br>* Normal saline placebo nebulization 15 minutes before sinus surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Modena Bleeding Score (MBS) assessing surgical field | 1= No bleeding, 2=Bleeding easily controlled by suctioning, washing or packing without any significant modification or slowing of surgical procedure, 3=Bleeding slowing surgical procedure, 4=Most of the maneuvers dedicated to bleeding control and 5=Bleeding that prevents every surgical procedure except those dedicated to bleeding control | After anesthesia induction to 60 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HR | Heart rate beat/min | Intraoperative duration | 
| MBP | Mean blood pressure mmHg | Intraoperative duration | 
| Anesthetic consumption | Extra doses of fentanyl and propofol and sevoflurane>2 | Anesthesia duration | 
| Postoperative complications | Recording any adverse effects to TXA e.g.nausea, vomiting and any visual disturbances | After operation to 24 hour |