Assessment of Nebulized Tranexamic Acid in Functional Endoscopic Sinus Surgery Using Modena Bleeding Score

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAssiut University

About this trial

The aim of this study is to investigate the effect of preoperative administration of intravenous or nebulized tranexamic acid on surgical field, blood loss, anesthetic consumption and hemodynamics of patients undergoing FESS.

Primary outcome Modena Bleeding Score (MBS) assessing surgical field Secondary outcome

1. Patient hemodynamics. 2. Anesthetic consumption, Extra doses of fentanyl and propofol and sevoflurane\>2 3. Postoperative complications: including any adverse effects to TXA e.g.nausea, vomiting, any visual disturbances, fits, and any thrombotic manifestation.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Either sex

age 18-65 years

ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia

normal accepted coagulation profile and hematocrit value ≥30

Disqualifiers

• chronic renal failure

liver cirrhosis

bleeding disorders

current anticoagulant therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tranexamic Acid (TXA)

    Drug

    To see if nebulised TXA is better to control blood loss in functional Endoscopic sinus surgery

  • Tranexamic Acid

    Drug

    To see if intravenous TXA is better to control blood loss in functional Endoscopic sinus surgery

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: IntravenousExperimental treatment 1 intervention
Group B: NebulizedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Modena Bleeding Score- assessing surgical field

* No bleeding -\>1. * Bleeding easily controlled by suctioning, washing, or packing without any significant modification or slowing of surgical procedure-\>2. * Bleeding slowing surgical procedure-\>3. * Most of the maneuvers dedicated to bleeding control -\>4. * Bleeding that prevents every surgical procedure except those dedicated to bleeding control-\>5.

Time frame
Baseline

Secondary outcomes

1

Measuring patient's Blood Pressure-> mmhg (unit of measure)

Time frame
Baseline
2

Measuring patient's Respiratory Rate-> breath per minute(unit of measure)

Time frame
Baseline
3

Measuring patient's Temperature-> Celsius(unit of measure)

Time frame
Baseline
4

Measuring patient's Pulse->Beat per minute(unit of measure)

Time frame
Baseline

Other outcomes

Sponsors and contacts

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