Middle Ear Disease
Conditions
Keywords
tranexamic acid, controlled hypotension, middle ear surgery
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.
Interventions
DRUGTransamine 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
Sponsors
TC Erciyes University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boezaart et al grading scale | 2-3 hours | 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. |
| Surgeon Satisfaction Score | 2-3 hours | 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed