Bezmialem Vakıf Universty
Istanbul, Fatih, 34093, Turkey (Türkiye)
NCT Number: NCT06301204
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Istanbul, Fatih, 34093, Turkey (Türkiye)
This prospective double blind clinical study was approved by the Bezmialem Vakif University Clinical Research Ethics Committee (2022-E.6706). All patients were provided detailed explanations of the surgical procedure and potential adverse events, underwent preoperative anesthesia assessments, and provided informed consent. A total of 60 patients were included in the study and were randomly assigned to three groups: Study Group 1 (N=20), Study Group 2 (N=20), and Control Group (N=20). In Study Group 1, patients received local anesthesia prior to bimaxillary osteotomy, followed by intravenous administration of 250 mg / 2.5 mL tranexamic acid before starting with the incision. In Study Group 2, patients also received local anesthesia before bimaxillary osteotomy, followed by intravenous administration of 250 mg / 2.5 mL tranexamic acid for le fort 1 and, a second dose of 250 mg / 2.5 mL tranexamic acid was administered for beginning of the sagittal split osteotomy. The Control Group, Group 3, did not receive any medication before or after surgery. All patients underwent bimaxillary surgery using the same surgical technique and same surgical team.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
tranexamic acid administration 250mg or 500 mg
onyl ıv saline (NaCl 0.09%)
Time frame: during the operation time (hour)
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.
Time frame: post operative 1-3-7 days
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.
Time frame: during the surgical time (hour)
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
Time frame: during the preoperative and post operative 2. day
Hemoglobin (Hgb) and Hematocrit (Hct) values were recorded preoperatively and second postoperative day.
Bezmialem Vakif University
Other
Evaluation Of The Effectiveness Of Tranexamic Acid Application Protocol With Different Doses On Bleeding, Edema And Physician Comfort In Bimaxillary Orthognathic Surgery Patients
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