Clinical trial NCT06777966: Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries
Official title: Effect of Preoperative Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries: a Randomized Controlled Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Nebulization
Intravenous
Surgical Field
Endoscopic Sinus Surgeries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: The mean Wormald intraoperative surgical field grading
timeFrame: 5 hours
Secondary outcomes:
measure: Total blood loss
timeFrame: 5 hours
measure: Bleeding rate
timeFrame: 5 hours
measure: Operation time
timeFrame: 5 hours
measure: Postoperative complications
timeFrame: 24 hours
measure: postoperative nasal bleeding
timeFrame: 48 hours
measure: postoperative intervention
timeFrame: 48 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University
Study officials:
affiliation: Cairo University
name: Nevan M Abbas Elmekawy, M.D.
role: STUDY_CHAIR
affiliation: Cairo University
name: Tamer M Khair, M.D.
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Kareem MA Nawwar, M.D.
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Nadia E M Gaballah, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: