An interventional study of Iron Isomaltoside 1000 and Normal saline in Facial Asymmetry, Retrognathism and Prognathism, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-03-20.
Sponsored by Yonsei University · Not applicable, Interventional, and Prevention
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.
27 studies on the registry are indexed under Facial Asymmetry; 10 are open to participants now.
This study's planned enrollment of 58 is above the median of 34 across 17 interventional studies indexed under Facial Asymmetry.
Browse Facial Asymmetry studies →Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the iron group are given Intravenous iron isomaltoside during operation.
Drug: Iron Isomaltoside 1000
Patients in the control group receive the same volume of normal saline during operation.
Drug: Normal saline
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.
Also known as: monofer®
Randomly selected patients in the control group receive an equivalent volume of normal saline as a placebo.
postoperative hemoglobin level
Postoperative hemoglobin concentration
Time frame: 1 day after surgery
postoperative hemoglobin level
Postoperative hemoglobin concentration
Time frame: 2 weeks after surgery
postoperative hemoglobin level
Postoperative hemoglobin concentration
Time frame: 4 weeks after surgery
hematogenous function
the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte
Time frame: 1 day after surgery
hematogenous function
the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte
Time frame: 2 weeks after surgery
hematogenous function
the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks after surgery
Plan to share: No
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Iron isomaltoside 1000