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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iron group | Experimental | Patients in the iron group are given Intravenous iron isomaltoside during operation. |
|
| control group | Placebo Comparator | Patients in the control group receive the same volume of normal saline during operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Isomaltoside 1000 | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bon-Nyeo Koo, M.D., Ph.D. | Contact | 82-2-2227-3919 | koobn@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine | Recruiting | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25900643 | Background | Johansson PI, Rasmussen AS, Thomsen LL. Intravenous iron isomaltoside 1000 (Monofer(R)) reduces postoperative anaemia in preoperatively non-anaemic patients undergoing elective or subacute coronary artery bypass graft, valve replacement or a combination thereof: a randomized double-blind placebo-controlled clinical trial (the PROTECT trial). Vox Sang. 2015 Oct;109(3):257-66. doi: 10.1111/vox.12278. Epub 2015 Apr 20. | |
| 27022297 |
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|
| Normal saline | Drug | Randomly selected patients in the control group receive an equivalent volume of normal saline as a placebo. |
|
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 |
| Background |
| Kalra PA, Bhandari S. Efficacy and safety of iron isomaltoside (Monofer((R))) in the management of patients with iron deficiency anemia. Int J Nephrol Renovasc Dis. 2016 Mar 10;9:53-64. doi: 10.2147/IJNRD.S89704. eCollection 2016. |
| 26678802 | Background | Oh AY, Seo KS, Lee GE, Kim HJ. Effect of preoperative autologous blood donation on patients undergoing bimaxillary orthognathic surgery: a retrospective analysis. Int J Oral Maxillofac Surg. 2016 Apr;45(4):486-9. doi: 10.1016/j.ijom.2015.11.008. Epub 2015 Dec 8. |
| 23950195 | Background | Litton E, Xiao J, Ho KM. Safety and efficacy of intravenous iron therapy in reducing requirement for allogeneic blood transfusion: systematic review and meta-analysis of randomised clinical trials. BMJ. 2013 Aug 15;347:f4822. doi: 10.1136/bmj.f4822. |
| 22705218 | Background | Choi BK, Yang EJ, Oh KS, Lo LJ. Assessment of blood loss and need for transfusion during bimaxillary surgery with or without maxillary setback. J Oral Maxillofac Surg. 2013 Feb;71(2):358-65. doi: 10.1016/j.joms.2012.04.012. Epub 2012 Jun 16. |
| ID | Term |
|---|---|
| D005146 | Facial Asymmetry |
| D063173 | Retrognathia |
| D011378 | Prognathism |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D008336 | Mandibular Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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