Facial Asymmetry, Retrognathism, Prognathism
Conditions
Brief summary
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
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.
Interventions
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.
DRUGNormal saline
Randomly selected patients in the control group receive an equivalent volume of normal saline as a placebo.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative hemoglobin level | 1 day after surgery | Postoperative hemoglobin concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hematogenous function | 1 day after surgery | the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte |
| quality of life(LASA) | 1 day after surgery | 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. |
Countries
South Korea
Contacts
Primary ContactBon-Nyeo Koo, M.D., Ph.D.
Outcome results
None listed