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IRCT201701221674N14 IRCT 2017-06-02 Vice chancellor for research, Shiraz University of Medical Sciences Efficacy of preoperative intravenous iron in perioperative blood management after rhinoplastic surgery Role of preoperative intravenous iron in perioperative blood management after rhinoplastic surgery: A Clinical Trial 2017-05-15 anticipated 60 Complete https://irct.ir/trial/1155 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. 3 Bleeding during rhinoplasty. Intervention 1: Intervention group: Patients in the interventional group (first group) will be received an intravenous VENOFER- iron sucrose injection, 500 mg dissolved in Norma salin 0.9 % via pump infusion bolus for 30 min. 25mg of Venofer should be infused over a period of 15 minutes. If no adverse events occur during the test dose, the remainder of the dose should be given at an infusion rate of not more than 50ml in 15 minutes. Intervention 2: Control group: Patients in the the second group will received " placebo" as same bolus volume dissolved in Norma salin 0.9 % in a 30-minute intravenous infusion.
public Saeed Tavanafar
Department of Maxillofacial Surgery, Shiraz School of Dentistry
Shiraz Iran (Islamic Republic of) +98 71 3620 3709 ghorbani14farhad@gmail.com Shiraz School of Dentistry scientific Hamid Reza Eftekharian
Shiraz University Of Medical Sciences, Shiraz Rajaei Hospital, Chamran Blvd., Shiraz
Shiraz Iran (Islamic Republic of) 7194815644 +98 71 3648 3783 eftekharhr@sums.ac.ir Shiraz School of Dentistry Iran (Islamic Republic of) Inclusion criteria: Male or female patients more than 18 years of age; no history of drug use; and willingness to cooperate in this study are enrolled. Exclusion criteria: patients with known allergy to the study drug; history of thromboembolic episodes; iron overload; hematologic diseases; hepatic and renal dysfunction; preoperative autologous blood donation and lack of signed informed consent will be excluded. 18 years 40 years Both 00 00 Treatment - Drugs Treatment - Drugs Intervention group: Patients in the interventional group (first group) will be received an intravenous VENOFER- iron sucrose injection, 500 mg dissolved in Norma salin 0.9 % via pump infusion bolus for 30 min. 25mg of Venofer should be infused over a period of 15 minutes. If no adverse events occur during the test dose, the remainder of the dose should be given at an infusion rate of not more than 50ml in 15 minutes. Control group: Patients in the the second group will received " placebo" as same bolus volume dissolved in Norma salin 0.9 % in a 30-minute intravenous infusion. Hemoglobin concentration. Timepoint: Pre operatio and post operation. Method of measurement: Questionnaire Lab. (g/dL). Transfused blood products. Timepoint: perioperatively. Method of measurement: number of units. Hemoglobin. Timepoint: Post operative. Method of measurement: g/dL. Blood Pressure. Timepoint: During administration. Method of measurement: Blood pressure monitoring. Vice chancellor for research, Shiraz University of Medical Sciences Approved 2017-02-06 Ethics committee Of Shiraz University Of Medical Sciences Shiraz University of Medical Sciences, Vice-Chancellors of Research and Technology, Zand Avenue, Shiraz Shiraz Iran (Islamic Republic of)