Does Tranexamic Acid Reduce the Need for Deliberate Hypotensive Anesthesia Within Orthognathic Surgery? A Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Surgeon's Analysis of Surgical Field Visualization
研究概览
简要总结
This prospective study will analyze the need for deliberate hypotensive anesthesia (DHA) during orthognathic surgery when tranexamic acid (TXA) is administered. DHA has been proven to be effective although it comes with multiple risks related to organ hypoperfusion including kidney injury, stroke, and cardiac ischemia. Therefore, it may be potentially safer for patients to avoid deliberate hypotensive anesthesia if TXA alone adequately controls blood loss and provides adequate surgical site visualization.
详细描述
Our goal is to enroll 50 patients. Patients will be recruited from Dr. Kinard's regularly scheduled orthognathic cases at UAB Highlands Hospital. The patient will be informed of the study in advance and have consent signed pre-operatively. Patients will be evaluated for the following variables: sex, age, weight at time of surgery, preoperative hemoglobin, and preoperative hematocrit. Patients will be included if they are undergoing bimaxillary orthognathic surgery at UAB Highlands Hospital. All patients treated with orthognathic surgery already are provided 1g of TXA perioperatively and this will be continued through this study. All patients will be treated with 1g of TXA perioperatively and the anesthesia team will be instructed to limit deliberate hypotensive anesthesia unless otherwise directed by the surgeon. Perioperative and post-operative measurements will include: estimated blood loss, pre and post-operative hemoglobin, pre and post-operative hematocrit, average mean arterial pressure throughout the case (MAP), maximum MAP (excluding induction and emergence), minimum MAP (excluding induction and emergence), total MAP time under 65 mmHg, length of procedure, and surgeon evaluation of visual field throughout the procedure utilizing Fromme's ordinal scale. Based on these factors, it will help determine the need for deliberate hypotensive anesthesia during orthognathic surgery when tranexamic acid is administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bimaxillary orthognathic surgery completed at UAB Highlands Hospital
排除标准
- •History of hypertension or previously diagnosed cardiac problems
- •Bleeding diathesis
- •TXA medically contraindicated
研究组 & 干预措施
Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia
干预措施: Avoidance of Deliberate Hypotensive Anesthesia (Other)
Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia
干预措施: TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION (Drug)
结局指标
主要结局
Surgeon's Analysis of Surgical Field Visualization
时间窗: through surgical procedure, and average of 2 hours
The surgeon will evaluate surgical field visibility using Fromme's ordinal scale. Fromme's ordinal scale (often referred to as the Fromme-Boezaart scale) is a 5-point, 0-5 visual grading system used by surgeons to assess the quality of the surgical field, primarily based on bleeding and suction frequency. It measures surgical conditions from 0 (no bleeding, perfectly dry) to 5 (severe bleeding, flooding the field).
Percentage of Hours to Maintain a Mean Arterial Pressure
时间窗: through surgical procedure, and average of 2 hours
Tracking mean arterial pressures throughout surgery, evaluating if patient's blood pressure can be reliably kept around patient's baseline instead of deliberate hypotensive anesthesia.
Average Volume of Blood Loss on a Scale
时间窗: through surgical procedure, and average of 2 hours
Volume of blood loss recorded during surgical case based on the Fromme's scale. Fromme's ordinal scale (often referred to as the Fromme-Boezaart scale) is a 5-point, 0-5 visual grading system used by surgeons to assess the quality of the surgical field, primarily based on bleeding and suction frequency. It measures surgical conditions from 0 (no bleeding, perfectly dry) to 5 (severe bleeding, flooding the field), widely applied in orthognathic, sinus, and spine surgeries to evaluate the effectiveness of techniques like hypotensive anesthesia.
次要结局
未报告次要终点
研究者
Brian Kinard
Assistant Professor
University of Alabama at Birmingham