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NCT Number: NCT06777966

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Cairo University

Cairo, Egypt

Location status: Recruiting

Location contact

Kareem MA Nawwar, M.D.

CONTACT

[email protected]

+201003878369

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. The mean Wormald intraoperative surgical field grading

    Time frame: 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 outcomes

  1. Total blood loss

    Time frame: 5 hours

    calculated by measuring the volume of the blood in the suction reservoir minus the normal saline used to wash the surgical field

  2. Bleeding rate

    Time frame: 5 hours

    calculated as the total blood loss divided by the surgical time

  3. Operation time

    Time frame: 5 hours

    Time starting from induction of anesthesia till completion of the surgical procedure

  4. Postoperative complications

    Time frame: 24 hours

    nausea, vomiting, anaphylaxis, visual impairment, seizure, venous thromboembolism

  5. postoperative nasal bleeding

    Time frame: 48 hours

    Incidence of postoperative nasal bleeding

  6. postoperative intervention

    Time frame: 48 hours

    Incidence of the need for postoperative intervention to control nasal bleeding

Study contacts

Contact information is provided by the study sponsor or research team.

Kareem MA Nawwar, M.D.

CONTACT

[email protected]

+201003878369

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Preoperative Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries: a Randomized Controlled Comparative Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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