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

Not Applicable

• Conditions: Retrognathism; Facial Asymmetry; Prognathism
• Interventions: Drug: Normal saline; Drug: Iron Isomaltoside 1000

• Registration Number: NCT03094182
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2017-03-02
• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-29
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-15
• Last Update Posted: 2019-03-20
• Primary Completion: 2019-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Normal saline	Patients in the control group receive the same volume of normal saline during operation.
iron group	Iron Isomaltoside 1000	Patients in the iron group are given Intravenous iron isomaltoside during operation.

Primary Outcome Measures

Name	Time	Method
postoperative hemoglobin level	4 weeks after surgery	Postoperative hemoglobin concentration

Secondary Outcome Measures

Name	Time	Method
hematogenous function	4 weeks after surgery	the hematogenous function measured by serum iron, ferritin, transferrin saturation, and total iron binding capacity, reticulocyte
quality of life(LASA)	4 weeks 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.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of