Bleeding Clinical Trial
Official title:
Evaluation Of The Effectiveness Of Tranexamic Acid Application Protocol With Different Doses On Bleeding, Edema And Physician Comfort In Bimaxillary Orthognathic Surgery Patients
Verified date | March 2024 |
Source | Bezmialem Vakif University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this clinical study conducted in accordance with the information in the literature is to compare the effects of administering tranexamic acid during orthognathic surgery, at different doses. Specifically, investigators aim to compare the effects of administering 1 ampoule IV (approximately 3 mg/kg) and 2 ampoules IV (approximately 6 mg/kg), and evaluate their impact on intraoperative bleeding (ml), surgical duration (min), postoperative swelling, and intraoperative surgical field evaluation (Fromme Scale), by comparing them with control group (applying no drug administration) patient data.
Status | Completed |
Enrollment | 60 |
Est. completion date | November 1, 2023 |
Est. primary completion date | November 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Patients with class 2 or class 3 dentofacial malformation who are planned to undergo bimaxillary orthognathic surgery. 2. Patients who have not had orthognathic surgery before 3. Patients without cleft lip and palate 4. Patients without systemic bleeding diets Exclusion Criteria: 1. Having a systemic disease that affects general health status 2. Presence of a malignant disease in the head and neck region 3. Patients who have previously undergone orthognathic surgery 4. Patients with any bleeding disorders |
Country | Name | City | State |
---|---|---|---|
Turkey | Bezmialem Vakif Universty | Istanbul | Fatih |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | intraoperative bleeding during the surgery (ml) | the primary outcome is this study is assessment of the intraoperative bleeding: Intraoperative bleeding will be calculated by subtracting the total amount of iv fluid and the amount of irrigation solutions used during surgery from the total amount of aspirate volume. | during the operation time (hour) | |
Secondary | postoperative edema calculation for the first 1-3 and 7 day (cm) | the first secondary outcome of this study is post operative edema: Prior to anesthesia induction, Tragus (Tra) and Gonion (Go) points were marked with methylene blue, and distances including Lateral Canthus - Gonion, Tragus-Commissure, and interincisal distances were measured with a paper ruler and recorded as preoperative measurements.Measurements of Lateral Canthus - Gonion, Tragus-Commissure, and Interincisal distances were repeated on postoperative days 1, 3, and 7 for evaluating postoperative edema. | post operative 1-3-7 days | |
Secondary | intraoperative surgical site evaluation (Fromme Scale) | the second secondary outcome is surgical site evaluation during the surgery. Surgeon evaluate the surgical site according to Fromme Scale per every one hour.
0 = No bleeding, virtually bloodless field = Bleeding so mild it is not even a surgical nuisance = Moderate bleeding, a nuisance but without interference with accurate dissection = Moderate bleeding that moderately compromises surgical dissection = Heavy but controllable that significantly interferes with dissection = Massive uncontrollable bleeding |
during the surgical time (hour) | |
Secondary | Hemoglobin (Hgb) and Hematocrit (Hct) values alteration preoperative and postoperative 2. day | Hemoglobin (Hgb) and Hematocrit (Hct) values were recorded preoperatively and second postoperative day. | during the preoperative and post operative 2. day |
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