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

Yonsei University

Status: Unknown

Conditions: Retrognathism; Prognathism; Facial Asymmetry

Treatments: Drug: Iron Isomaltoside 1000; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03094182

4-2016-1146

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 19 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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58 participants in 2 patient groups, including a placebo group

iron group

Experimental group

Description:

Patients in the iron group are given Intravenous iron isomaltoside during operation.

Treatment:

Drug: Iron Isomaltoside 1000

control group

Placebo Comparator group

Description:

Patients in the control group receive the same volume of normal saline during operation.

Treatment:

Drug: Normal saline