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

Phase 4

Recruiting

• Conditions: Nebulization; Intravenous; Surgical Field; Endoscopic Sinus Surgeries
• Interventions: Drug: nebulized tranexamic acid; Drug: intravenous tranexamic acid

• Registration Number: NCT06777966
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-11
• Study First Submitted QC: 2025-01-11
• Study Start: 2025-01-18
• Last Update Submitted: 2025-01-19
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-06-15
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebulized group	nebulized tranexamic acid	patients will receive nebulized tranexamic acid
Intravenous group	intravenous tranexamic acid	patients will receive intravenous tranexamic acid

Primary Outcome Measures

Name	Time	Method
The mean Wormald intraoperative surgical field grading	5 hours	The mean value of Wormald intraoperative surgical field grading throughout the intraoperative period, where 0 means no bleeding and 10 means severe bleeding with nasal cavity filling rapidly

Secondary Outcome Measures

Name	Time	Method
Operation time	5 hours	Time starting from induction of anesthesia till completion of the surgical procedure
Postoperative complications	24 hours	nausea, vomiting, anaphylaxis, visual impairment, seizure, venous thromboembolism
postoperative nasal bleeding	48 hours	Incidence of postoperative nasal bleeding
Total blood loss	5 hours	calculated by measuring the volume of the blood in the suction reservoir minus the normal saline used to wash the surgical field
Bleeding rate	5 hours	calculated as the total blood loss divided by the surgical time
postoperative intervention	48 hours	Incidence of the need for postoperative intervention to control nasal bleeding

Trial Locations

Locations (1)

Faculty of Medicine, Cairo University; 🇪🇬 Cairo, Egypt