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

NCT ID: NCT06777966

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-18
• Study Completion Date: 2025-07-01

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.

Conditions

Nebulization; Intravenous; Surgical Field; Endoscopic Sinus Surgeries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Nebulized group

patients will receive nebulized tranexamic acid

Group Type: ACTIVE_COMPARATOR

nebulized tranexamic acid

Intervention Type: DRUG

patients will receive a preoperative nebulizer session of 500 mg of tranexamic acid. To ensure the blinding of the participating anesthetist and patient, patients in this group will receive an intravenous drip of 100 ml of 0.9% normal saline.

Intravenous group

patients will receive intravenous tranexamic acid

Group Type: ACTIVE_COMPARATOR

intravenous tranexamic acid

Intervention Type: DRUG

patients will receive a preoperative intravenous drip of TXA at a dose of 15 mg/kg in 100 ml of normal saline. To ensure blinding this group patients will receive 5 ml of 0.9% normal saline nebulizer session.

Interventions

nebulized tranexamic acid

patients will receive a preoperative nebulizer session of 500 mg of tranexamic acid. To ensure the blinding of the participating anesthetist and patient, patients in this group will receive an intravenous drip of 100 ml of 0.9% normal saline.

Intervention Type: DRUG

intravenous tranexamic acid

patients will receive a preoperative intravenous drip of TXA at a dose of 15 mg/kg in 100 ml of normal saline. To ensure blinding this group patients will receive 5 ml of 0.9% normal saline nebulizer session.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Kareem Mohammed Assem Nawwar

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nevan M Abbas Elmekawy, M.D.

Role: STUDY_CHAIR

Cairo University

Tamer M Khair, M.D.

Role: STUDY_DIRECTOR

Cairo University

Kareem MA Nawwar, M.D.

Role: STUDY_DIRECTOR

Cairo University

Nadia E M Gaballah, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of Medicine, Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Kareem MA Nawwar, M.D.

Role: CONTACT

drknawwar@cu.edu.eg

+201003878369

Facility Contacts

Kareem MA Nawwar, M.D.

Role: primary

drknawwar@cu.edu.eg

+201003878369

Other Identifiers

MD-206-2024

Identifier Type: -

Identifier Source: org_study_id