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

Middle Ear Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06434636
• Other study ID #: 2024/88
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: TC Erciyes University
• Contact: Talha ERSOY, MD
• Phone: +905316682730
• Email: drdrtalhaersoy[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ear Diseases
• Middle Ear Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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