Evaluation Of The Effectiveness Of Tranexamic Acid Application Protocol With Different Doses On Bleeding, Edema And Physician Comfort In Bimaxillary Orthognathic Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- intraoperative bleeding during the surgery (ml)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with class 2 or class 3 dentofacial malformation who are planned to undergo bimaxillary orthognathic surgery.
- •Patients who have not had orthognathic surgery before
- •Patients without cleft lip and palate
- •Patients without systemic bleeding diets
排除标准
- •Having a systemic disease that affects general health status
- •Presence of a malignant disease in the head and neck region
- •Patients who have previously undergone orthognathic surgery
- •Patients with any bleeding disorders
研究组 & 干预措施
control group
control group patient give no drug administration during bimaxillary orthognathic surgery.
干预措施: Saline (Drug)
group 1(intravenous administration of 250 mg tranexamic acid)
group 1 (TRANEXEL 250 mg/5 mL) patients administered 250 mg tnx acid during the whole bimaxillary orthognathic surgery
干预措施: Tranexamic acid injection (Drug)
group 2 (intravenous administration of 500 mg tranexamic acid)
group 2 (TRANEXEL 250 mg/5 mL) patients administered 500 mg tnx acid during the whole surgery.
干预措施: Tranexamic acid injection (Drug)
结局指标
主要结局
intraoperative bleeding during the surgery (ml)
时间窗: 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.
次要结局
- intraoperative surgical site evaluation (Fromme Scale)(during the surgical time (hour))
- Hemoglobin (Hgb) and Hematocrit (Hct) values alteration preoperative and postoperative 2. day(during the preoperative and post operative 2. day)
- postoperative edema calculation for the first 1-3 and 7 day (cm)(post operative 1-3-7 days)