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

NCT06777966 | Recruiting Phase 4

• 1 other identifier: MD-206-2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The mean Wormald intraoperative surgical field grading

  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

  5 hours

Secondary Outcomes (6)

• Total blood loss

  5 hours

• Bleeding rate

  5 hours

• Operation time

  5 hours

• Postoperative complications

  24 hours

• postoperative nasal bleeding

  48 hours

Study Arms (2)

Nebulized group

ACTIVE COMPARATOR

patients will receive nebulized tranexamic acid

Drug: nebulized tranexamic acid

Intravenous group

ACTIVE COMPARATOR

patients will receive intravenous tranexamic acid

Drug: intravenous tranexamic acid

Interventions

nebulized tranexamic acid 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.

Nebulized group

intravenous tranexamic acid 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.

Intravenous group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60 years.
• American Society of Anesthesiologists (ASA) class I and II patients.
• Endoscopic sinus surgeries under general anesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Egypt

RECRUITING

Study Officials

• Nevan M Abbas Elmekawy, M.D.

  Cairo University

  STUDY CHAIR

• Tamer M Khair, M.D.

  Cairo University

  STUDY DIRECTOR

• Kareem MA Nawwar, M.D.

  Cairo University

  STUDY DIRECTOR

• Nadia E M Gaballah, M.Sc.

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kareem MA Nawwar, M.D.

CONTACT

+201003878369; drknawwar@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 11, 2025
• First Posted: January 16, 2025
• Study Start: January 18, 2025
• Primary Completion: June 15, 2025
• Study Completion: July 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

EG (1)