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NCT Number: NCT06434636

The Effect of Tranexamic Acid in Endoscopic and Microscopic Ear Surgery Cases on Surgeon Satisfaction

By using tranexamic acid, an antifibrinolytic drug, the aim is to prevent the restriction of the field of view of the surgical field due to bleeding in middle ear microscopic and endoscopic surgery operations in which controlled hypotension is applied, and therefore the prolongation of the surgical time, and to increase surgeon satisfaction.

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Key information

Conditions

Middle Ear Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes Üniversitesi

Kayseri, Talas, 38000, Turkey (Türkiye)

About this study

After obtaining approval from our university and the Turkish Ministry of Health's pharmaceutical and medical device agency and written consent from the patients, 100 patients who underwent middle ear surgery using controlled hypotension under general anesthesia will be included in the study.

The study will be conducted in a randomized controlled, double-blind manner. Patients between the ages of 18-65 and with American Society of Anesthesiologists (ASA) Scores I and II will be included in the study. Patients will be divided into two groups: Intervention (M) and Control (C). Just before the operation begins, 10 mg/kg tranexamic acid (TXA) will be administered to the intervention group in 100 mL of 0.9% physiological saline (SF) solution in 15 minutes. 100 mL of 0.9% SF solution will be sent to the control group in 15 minutes. At the end of the operation, the operator's quality of vision of the surgical field will be recorded by questioning the surgeon's satisfaction with the Boezaart Score and the Surgeon Satisfaction Score.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Individuals between the ages of 18-65
  • Individuals with ASA I (no additional disease) or ASA II (mild systemic disease)
  • Those who do not have a disease such as thrombophilia or bleeding diathesis will be included in the study

Exclusion criteria

  • Patients with ASA III (those with uncontrolled chronic disease) or above
  • Patients with cardiovascular disease, congestive heart failure, coronary artery disease, cerebrovascular insufficiency, renal or hepatic failure
  • Patients with thrombophilia, bleeding diathesis, coagulation defects
  • Pregnant patients
  • Those with a history of any allergic reaction to tranexamic acid and its derivatives will be excluded from the study

Treatment and study plan

Transamine 10% IV/IM Solution for Injection

Drug

10 mg/kg tranexamic acid (Transamine 10% IV/IM Injectable Solution) will be placed into 100 cc physiological saline through the appropriate vascular access and injected within 15 minutes.

Other names: tranexamic acid

%0.9 Saline

Drug

100 cc %0.9 Normal Saline will be injected through the appropriate vascular access within 15 minutes

Other names: Physiological Saline, %0.9 NaCl

Primary outcomes

  1. Boezaart et al grading scale

    Time frame: 2-3 hours

    At the end of a surgery, the surgical field was graded in terms of bleeding by the surgeon using the scale used by Boezaart et al in 1995;

    0 : No bleeding (cadaveric conditions).

    • : Slight bleeding: no suctioning required.
    • : Slight bleeding: occasional suctioning required.
    • : Slight bleeding: frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.
    • : Moderate bleeding: frequent suctioning required and bleeding threatens surgical field directly after suction is removed.
    • : Severe bleeding: constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible.

  2. Surgeon Satisfaction Score

    Time frame: 2-3 hours

    At the and of surgery , surgeon's satisfaction with surgical field quality was also graded in a 5-item Likert scale, where 1 = poor and 5 = excellent

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

The Effect of The Use of Low Dose Tranexamic Acid on Surgeon Satisfaction, Side Effects and Complications in Endoscopic and Microscopic Ear Surgery Cases Which Are Used With Controlled Hypotension

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 30, 2024
Registry last updated
Sep 8, 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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