Chronic rhinosinusitis, Postoperative bleeding, Endoscopic sinus surgery, Tranexamic acid, Magnesium sulfate. Chronic sinusitis, unspecified
Conditions
Interventions
Intervention 1: Intervention Group 1 (Tranexamic Acid):Patients in this group will receive 15 mg/kg of tranexamic acid diluted in 100 mL of normal saline as an intravenous infusion during surgery. Int
Sponsors
Arak University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients aged between 18 and 65 years. Patients diagnosed with chronic rhinosinusitis confirmed by clinical examination and sinus CT imaging Patients who are candidates for elective endoscopic sinus and nasal surgery (ESS) due to failure of medical treatments. Patients who have signed an informed consent form to participate in the study. Patients without hypersensitivity to tranexamic acid or magnesium sulfate, confirmed through medical history and necessary tests. Patients without a history of coagulopathy or use of anticoagulant medications. Patients without severe cardiovascular, renal, or hepatic diseases.
Exclusion criteria
Exclusion criteria: Identification of anatomical abnormalities during endoscopic examination Occurrence of acute adverse reactions related to either drug during surgery, such as allergic reactions or serious side effects (e.g., severe hypotension, muscle weakness, or respiratory depression) that interfere with treatment continuation. Uncontrolled severe intraoperative bleeding requiring additional interventions or medications that could affect the study outcomes. Development of medical emergencies during or after surgery that make continued participation in the study impossible or unsafe. Patient non-compliance with the study protocol, including failure to follow medical instructions or attend postoperative follow-up visits. The need for additional medications or therapeutic interventions that may interfere with the study results or the effectiveness of the investigated drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bleeding severity (patient-reported VAS). Timepoint: Postoperative day 1 and day 7. Method of measurement: The severity of bleeding is measured by the patient using the Visual Analogue Scale (VAS). The patient marks the bleeding intensity on a 10-centimeter line ranging from “no bleeding” to “uncontrolled bleeding.”. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include postoperative edema (swelling) and ecchymosis (bruising), which will be assessed by the evaluation team on postoperative days 1 and 7. Timepoint: The time points for measuring the secondary outcomes are postoperative day 1 and day 7. Method of measurement: Postoperative edema (swelling) and ecchymosis (bruising) will be assessed visually by the evaluation team using standard rating scales. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBenyamin Rahmati
Arak University of Medical Sciences
Outcome results
None listed