Efficacy of Intravenous Iron Therapy in Maintaining Hemoglobin Concentration on Patients Undergoing Bimaxillary Orthognathic Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- postoperative hemoglobin level
研究概览
简要总结
The aim of this study is to evaluate the effect of Intravenous iron isomaltoside on maintaining hemoglobin concentration in patients undergoing bimaxillary orthognathic surgery. Fifty-eight patients, aged 19 to 40 years, scheduled for Bimaxillary orthognathic surgery will be divided into monofer (n=29) and control (n=29) groups. Randomly selected patients of the ulinastatin group are given intravenous iron isomaltoside. In contrast, patients in the control group receive an equivalent volume of normal saline as a placebo. The primary endpoints are postoperative hemoglobin concentration.
详细描述
Bimaxillary orthognathic surgery is widely used to correct dentofacial anomaly and bimaxillary prognathism. However, the complicated vascularity of the surgical site and limited visual field can lead to unexpected bleeding. Intravenous iron isomaltoside 1000 (monofer®) significantly increased the hemoglobin level and prevented anemia 4 weeks after cardiac surgery. The aim of this study is to evaluate the effect of Intravenous iron isomaltoside on maintaining hemoglobin concentration in patients undergoing bimaxillary orthognathic surgery. Fifty-eight patients, aged 19 to 40 years, scheduled for Bimaxillary orthognathic surgery will be divided into monofer (n=29) and control (n=29) groups. Randomly selected patients of the ulinastatin group are given intravenous iron isomaltoside. In contrast, patients in the control group receive an equivalent volume of normal saline as a placebo. The primary endpoints are postoperative hemoglobin concentration.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who are scheduled to undergo bimaxillary orthognathic surgery
- •American Society of Anesthesiologists (ASA) physical status I-II
排除标准
- •hematologic disease
- •renal-related anemia
- •hepatitis
- •pregnancy
- •hypersensitivity to iron
- •severe atopic disease
- •allergic to drugs
研究组 & 干预措施
iron group
Patients in the iron group are given Intravenous iron isomaltoside during operation.
干预措施: Iron Isomaltoside 1000 (Drug)
control group
Patients in the control group receive the same volume of normal saline during operation.
干预措施: Normal saline (Drug)
结局指标
主要结局
postoperative hemoglobin level
时间窗: 4 weeks after surgery
Postoperative hemoglobin concentration
次要结局
- hematogenous function(4 weeks after surgery)
- quality of life(LASA)(4 weeks after surgery)