Clinical trial NCT06434636: The Effect of Tranexamic Acid in Endoscopic and Microscopic Ear Surgery Cases on Surgeon Satisfaction
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Middle Ear Disease
Keywords: tranexamic acid
controlled hypotension
middle ear surgery
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Boezaart et al grading scale
timeFrame: 2-3 hours
measure: Surgeon Satisfaction Score
timeFrame: 2-3 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: TC Erciyes University
name: Talha ERSOY, MD
role: STUDY_CHAIR
References: