Association Between Weight-Based Equivalent of Fixed 1 g Tranexamic Acid and Intraoperative Remifentanil Titration Frequency and Anesthesiologist Workload in Septorhinoplasty: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Intraoperative Remifentanil Titration Frequency
研究概览
简要总结
This prospective observational cohort study aims to investigate whether the weight-based equivalent (mg/kg) of a fixed 1 g dose of tranexamic acid administered during septorhinoplasty is associated with intraoperative remifentanil titration frequency and perceived anesthesiologist workload. Although tranexamic acid is routinely given as a fixed dose, its mg/kg equivalent varies according to patient weight and may influence hemodynamic management during controlled hypotension. The primary outcome is the total number of remifentanil infusion rate adjustments during surgery. Secondary outcomes include total remifentanil consumption and postoperative anesthesiologist workload assessed using the NASA Task Load Index (NASA-TLX).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Elective septorhinoplasty under general anesthesia
- •Intraoperative administration of fixed 1 g intravenous tranexamic acid as part of routine practice
- •Controlled hypotension strategy applied intraoperatively
- •Surgery duration between 60-240 minutes
- •Complete intraoperative hemodynamic and drug titration records available
排除标准
- •Emergency surgery
- •Additional major surgical procedure performed in the same session
- •Known coagulation disorder
- •Contraindication to tranexamic acid
- •History of thromboembolic disease
- •Chronic opioid use or opioid tolerance
- •Chronic pain syndrome
- •Regular use of sedatives, benzodiazepines, or CNS depressants
- •Severe cardiac, renal, or hepatic failure
- •Uncontrolled hypertension or significant arrhythmia
- •Preoperative hemoglobin <10 g/dL
- •Major intraoperative complication
- •Incomplete or missing intraoperative data
结局指标
主要结局
Intraoperative Remifentanil Titration Frequency
时间窗: Intraoperative period (from induction of anesthesia to end of surgery).
Total number of intraoperative remifentanil infusion rate adjustments (each increase or decrease counted as one intervention) recorded during septorhinoplasty.
次要结局
未报告次要终点
研究者
İlke Dolgun
Assoc. prof
Istinye University