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

NCT06434636 | Completed DMC

• 1 other identifier: 2024/88
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Middle Ear Disease

Keywords

tranexamic acid; controlled hypotension; middle ear surgery

Outcome Measures

Primary Outcomes (2)

• 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). 1. : Slight bleeding: no suctioning required. 2. : Slight bleeding: occasional suctioning required. 3. : Slight bleeding: frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed. 4. : Moderate bleeding: frequent suctioning required and bleeding threatens surgical field directly after suction is removed. 5. : 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

Study Arms (2)

Intervention Group (I)

ACTIVE COMPARATOR

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

Control Group (C)

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: tranexamic acid

Intervention Group (I)

%0.9 Saline DRUG

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

Also known as: Physiological Saline, %0.9 NaCl

Control Group (C)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: All genders will be included this study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes Üniversitesi

Kayseri, Talas, 38000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Tranylcypromine; Injections; Tranexamic Acid; Sodium Chloride

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Drug Administration Routes; Drug Therapy; Therapeutics; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Talha ERSOY, MD

  TC Erciyes University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 30, 2024
• Study Start: December 1, 2024
• Primary Completion: May 5, 2025
• Study Completion: August 6, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

TU (1)