Clinical trial NCT04905901: Nebulized Tranexamic Acid in Sinus Surgery
Official title: Does Nebulized Tranexamic Acid Affect Operative Field in Sinus Surgery? A Double Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Bleeding Nose
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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)

Eligibility criteria: 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.

Primary outcomes:
measure: the Modena Bleeding Score (MBS) assessing surgical field
timeFrame: After anesthesia induction to 60 minute
Secondary outcomes:
measure: HR
timeFrame: Intraoperative duration
measure: MBP
timeFrame: Intraoperative duration
measure: Anesthetic consumption
timeFrame: Anesthesia duration
measure: Postoperative complications
timeFrame: After operation to 24 hour
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit
state: Assuit
Study officials:
References: