NCT06777966

Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries

Recruiting now Phase 4 Last updated 22 January 2025

What this trial tests

Phase 4 trial testing nebulized tranexamic acid in Nebulization in 60 participants. Currently enrolling.

Timeline

18 January 2025

Primary endpoint
15 June 2025

1 July 2025

Quick facts

Lead sponsor	Cairo University
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	60
Start date	18 January 2025
Primary completion	15 June 2025
Estimated completion	1 July 2025
Sites	1 location across Egypt

Drugs / interventions tested

• nebulized tranexamic acid — full drug profile →
• intravenous tranexamic acid — full drug profile →

Conditions studied

• Nebulization — all drugs for Nebulization →
• Intravenous — all drugs for Intravenous →
• Surgical Field — all drugs for Surgical Field →
• Endoscopic Sinus Surgeries — all drugs for Endoscopic Sinus Surgeries →

Sponsor

Cairo University

Who can join

Adults 18 to 60, any sex, with Nebulization or Intravenous. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.