NCT06434636

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: TC Erciyes University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Middle Ear Disease

Interventions

Type	Name	Description
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.
DRUG	%0.9 Saline	100 cc %0.9 Normal Saline will be injected through the appropriate vascular access within 15 minutes

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-05-05
• Completion: 2025-08-06
• First posted: 2024-05-30
• Last updated: 2025-09-08

Locations

1 site across 1 country: Turkey (Türkiye)