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

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

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.

Study Overview

• Status: Completed
• Conditions: Middle Ear Disease
• Intervention / Treatment: Drug: Transamine 10% IV/IM Solution for Injection; Drug: %0.9 Saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Talas
    • Kayseri, Talas, Turkey (Türkiye), 38000
      • Erciyes Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group (I); Patients' vital values will be recorded before surgery.10 mg/kg tranexamic acid (Transamine 10% IV/IM Solution for Injection) is added into 100 cc serum through the appropriate vascular access and injected for 15 minutes.The amount of bleeding in the surgical field will be evaluated by the surgeon using the Boezaart Scale.Intraoperatively, hemodynamic changes such as bradycardia, tachycardia, arrhythmia and agents used such as vasopressors, antiarrhythmics and vagolytics will be recorded in the patient.Post-Operatively the surgeon's quality of vision will be questioned with the Surgeon Satisfaction Scale.Postoperative 0th, 12th, and 24th developments - the presence of vomiting and postoperative complaints will be questioned.The presence of bleeding or complications in the first 2 weeks after surgery will be questioned.The presence of thromboembolic events and other services will be questioned within 12 weeks after surgery.	Drug: Transamine 10% IV/IM Solution for Injection; 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
Placebo Comparator: Control Group (C); Preoperative vital values of the patients will be recorded.100 cc of physiological saline will be sent through the appropriate vascular access in 15 minutes. The amount of bleeding in the surgical field will be evaluated by the surgeon using the Boezaart Scale. Intraoperatively, hemodynamic changes such as bradycardia, tachycardia, arrhythmia that develop in the patient, and agents such as vasopressors, antiarrhythmics, and vagolytics used will be recorded. Postoperatively the surgeon's quality of vision will be questioned with the Surgeon Satisfaction Scale. The presence of nausea and vomiting and postoperative complaints will be questioned at the 0th, 12th, and 24th postoperative hours. The presence of surgical bleeding or complications that occur in the first 2 weeks of surgery will be questioned. The presence of thromboembolic events and other complications will be questioned within 12 weeks postoperatively.	Drug: %0.9 Saline; 100 cc %0.9 Normal Saline will be injected through the appropriate vascular access within 15 minutes; Other Names: %0.9 NaCl; Physiological Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boezaart et al grading scale	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.	2-3 hours
Surgeon Satisfaction Score	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	2-3 hours

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Study Chair: Talha ERSOY, MD, TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): May 5, 2025
• Study Completion (Actual): August 6, 2025

Study Registration Dates

• First Submitted: May 19, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: tranexamic acid; controlled hypotension; middle ear surgery
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Organic Chemicals; Pharmaceutical Preparations; Therapeutics; Drug Administration Routes; Drug Therapy; Carboxylic Acids; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Acids, Carbocyclic; Propylamines; Cyclohexanecarboxylic Acids; Tranexamic Acid; Tranylcypromine; Injections; Saline Solution
• Other Study ID Numbers: 2024/88

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No