Efficacy of Intravenous Iron Therapy in Maintaining Hemoglobin Concentration on Patients Undergoing Bimaxillary Orthognathic Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Intravenous Iron Therapy in Maintaining Hemoglobin Concentration on Patients Undergoing Bimaxillary Orthognathic Surgery

Conditions
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Facial Asymmetry, Retrognathism, Prognathism

Intervention / Treatment
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* Drug: Iron Isomaltoside 1000
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who are scheduled to undergo bimaxillary orthognathic surgery American Society of Anesthesiologists (ASA) physical status I-II Exclusion Criteria: hematologic disease renal-related anemia hepatitis pregnancy hypersensitivity to iron severe atopic disease allergic to drugs

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iron group<br>Patients in the iron group are given Intravenous iron isomaltoside during operation. | Drug: Iron Isomaltoside 1000<br>* Randomly selected patients of the monofer group are given 1000mg of iron isomaltoside, which are mixed in 100ml normal saline, intravenous after induction for 30 minutes.<br>* Other names: monofer®;|
| Placebo Comparator: control group<br>Patients in the control group receive the same volume of normal saline during operation. | Drug: Normal saline<br>* Randomly selected patients in the control group receive an equivalent volume of normal saline as a placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative hemoglobin level | Postoperative hemoglobin concentration | 1 day after surgery | 
| postoperative hemoglobin level | Postoperative hemoglobin concentration | 2 weeks after surgery | 
| postoperative hemoglobin level | Postoperative hemoglobin concentration | 4 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hematogenous function | the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte | 1 day after surgery | 
| hematogenous function | the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte | 2 weeks after surgery | 
| hematogenous function | the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte | 4 weeks after surgery | 
| quality of life(LASA) | The quality of life measured by LASA(Linear Analogue Self Assessment) questionnaire. LASA includes five simple items, each of which targets a specific domain of quality of life. Five single items(overall, physical, emotional, spiritual, intellectual) asking respondents to rate, on zero to ten scales, their perceived level of functioning. | 1 day after surgery | 
| quality of life(LASA) | The quality of life measured by LASA(Linear Analogue Self Assessment) questionnaire. LASA includes five simple items, each of which targets a specific domain of quality of life. Five single items(overall, physical, emotional, spiritual, intellectual) asking respondents to rate, on zero to ten scales, their perceived level of functioning. | 2 weeks after surgery | 
| quality of life(LASA) | The quality of life measured by LASA(Linear Analogue Self Assessment) questionnaire. LASA includes five simple items, each of which targets a specific domain of quality of life. Five single items(overall, physical, emotional, spiritual, intellectual) asking respondents to rate, on zero to ten scales, their perceived level of functioning. | 4 weeks after surgery |