Effect of Preoperative Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries: a Randomized Controlled Comparative Study
| Registry | NCT06777966 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: triple, other |
| Enrollment | 60 (Actual) |
| Sponsor | Cairo University (Other) |
| Conditions | Nebulization, Intravenous, Surgical Field, Endoscopic Sinus Surgeries |
| Interventions | nebulized tranexamic acid, intravenous tranexamic acid (Drug) |
| Dates | start 2025-01-24, primary completion 2025-07-30, completion 2025-08-10, first posted 2025-01-16, last updated 2026-09-22 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Nebulization All trials for Intravenous All trials of nebulized tranexamic acid All trials of intravenous tranexamic acid
Intraoperative bleeding is one of the vital problems for anesthesiologists and surgeons, during endoscopic nasal surgery; where the surgical field is very limited and surrounded by vital structures. The tinniest amount of blood in such surgical field can obscure the anatomy and clog the tip of the endoscope, requiring repeated irrigations and suctioning; both of which have traumatic effects on the friable nasal mucosa. Anesthetic techniques to minimize bleeding during endoscopic nasal surgery are of primary importance for a safe and effective procedure, reducing operative time and shortening post-operative recovery.
Good surgical conditions could be achieved with systemic, topical, or regional anesthetic techniques. The use of topical and regional techniques has been gaining popularity in recent years as an alternative to the administration of heavy premedication, high narcotic doses, intravenous lignocaine, clonidine, calcium channel blockers, sodium nitroprusside, beta-adrenergic blockers, and magnesium sulfate, which may produce a lack of alertness, respiratory depression, hypoxia, nausea and vomiting, and delayed recovery.
Recent studies have shown that the use of tranexamic acid could be a safe and effective management option for hemostasis in a wide range of specialties. Tranexamic acid (TXA) is a synthetic lysine derivative that blocks the lysine binding site on plasminogen, thus inactivating its conversion to plasmin and hence attenuating its fibrinolysis effects. When given as a one-time operative systemic dose, it can reduce intraoperative surgical blood loss. More recently, it has been used in its nebulized or topical form to treat bleeding in anatomically sequestered areas. Its use has been described for epistaxis, cancer-related hemoptysis, and post-tonsillectomy bleeding. Though systemic doses of tranexamic acid have proven their efficiency in reducing intraoperative bleeding, other forms of administration have not been widely researched. The use of nebulized form is expected to provide a targeted route and localized effect with reduced systemic side effects. Adverse effects of systemic administration of tranexamic acid include seizures, nausea, vomiting, diarrhea, pulmonary embolism, deep vein thrombosis, anaphylaxis, and other visual disturbance.
The purpose of this study was to assess the effect of pre-emptive nebulized tranexamic acid versus intravenous tranexamic acid on endoscopic visualization and bleeding rate during endoscopic sinus surgeries.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Nebulized group | Active comparator | Drug: nebulized tranexamic acid | patients will receive nebulized tranexamic acid |
| Intravenous group | Active comparator | Drug: intravenous tranexamic acid | patients will receive intravenous tranexamic acid |
Sex: All, ages: 18 Years to 60 Years
Inclusion Criteria: * Age between 18 and 60 years. * American Society of Anesthesiologists (ASA) class I and II patients. * Endoscopic sinus surgeries under general anesthesia. Exclusion Criteria: * Patient's refusal. * American Society of Anesthesiologists (ASA) class III or IV patients. * Underlying uncontrolled hypertension. * Known history bleeding disorder. * Patients on anticoagulant therapy. * Allergy to any of the drugs utilized in this study. * History of nonsteroidal anti-inflammatory drugs within 48 hours of scheduled surgery. * Inadvertent intra-operative vascular injury.
| Facility | City | Country | Status |
|---|---|---|---|
| Faculty of Medicine, Cairo University | Cairo, Cairo Governorate | Egypt |