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IRCT20130814014359N5 IRCT 2019-01-22 Rasht University of Medical Sciences The effect of vitamin C on stress intensity in long-term fasting Investigating the effects of intravenous Vitamin C on stress response severity in prolonged preoperative fasting time in abdominal hysterectomy surgery 2019-02-20 anticipated 60 Complete https://irct.ir/trial/36689 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomized with quadruple blocks and divide into two groups of treatment and control. The randomization unit is individual. In this randomization, we do not have a layer and we use a random numbers table tool. After providing the list, we will give it to the anesthetic technician who is not a member of the research team, to categorize patients in control or treatment groups based on the list, Blinding description: Vitamin C and placebo (normal saline) are prepared by an anesthetic technician who is not a member of this research group and will be coded in similar 5-millimeter syringes and will be given to the responsible anesthesiologist. By her, the drugs are injected into 500 ml of normal saline and will be infused within 20 minutes. In this study patients, the responsible anesthesiologist and the assessor are blind. 3 Stress responses in prolonged preoperative fasting In abdominal hysterectomy surgery. Intervention 1: Intervention group: The vitamin C group: when the patient's fasting time is about twelve hours, one gram vitamin C (500 milligrams in 5 milliliters, manufactured by Osveh Pharmaceutical Company) will be injected into 500-milliliter normal saline serum and infused within 20 minutes. Intervention 2: Control group: placebo group: 5 milliliters of normal saline will be injected into 500-milliliter normal saline serum and infused within 20 minutes. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is not decided yet
public Vali Imantalab
Heshmat Hospital
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3366 9066 valiimantalab@gmail.com Rasht University of Medical Sciences scientific Valli Imantalab
15th khordad street, Emam khomeini boulevard, Dr.Heshmat hospital
Rasht Iran (Islamic Republic of) 4193955599 +98 13 1666 2360 valiimantalab@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients, candidate for elective abdominal hysterectomy Age between 35-65 Fasting time, more than 12 hours 35 years 65 years Female Patient dissatisfaction Hysterectomy in malignancy Accompanying surgery Patients under treatment with steroids, including inflammatory and rheumatic diseases endometriosis Diabetes type one and two Pelvic inflammatory diseases transfusion during surgery F43 Reaction to severe stress, and adjustment disorders Prevention Prevention Intervention group: The vitamin C group: when the patient's fasting time is about twelve hours, one gram vitamin C (500 milligrams in 5 milliliters, manufactured by Osveh Pharmaceutical Company) will be injected into 500-milliliter normal saline serum and infused within 20 minutes. Control group: placebo group: 5 milliliters of normal saline will be injected into 500-milliliter normal saline serum and infused within 20 minutes. Changes in CRP factor levels in blood. Timepoint: Prior to infusion of vitamin C, 24 and 48 hours after surgery. Method of measurement: Taking blood sample. Changes glucose levels in blood. Timepoint: Prior to infusion of vitamin C, 24 and 48 hours after surgery. Method of measurement: Taking blood sample. Systolic and diastolic blood pressure changes. Timepoint: Prior to infusion of vitamin C, 24, 48 hours after surgery. Method of measurement: Measuring the patient's blood pressure. Changes in heart rate. Timepoint: Prior to infusion of vitamin C, 24, 48 hours after surgery. Method of measurement: Getting the patient's pulse. Duration of staying in the hospital. Timepoint: discharge day. Method of measurement: Number of days in hospital. Rasht University of Medical Sciences Approved 2018-12-29 Ethics Committee Of Guilan University Of Medical Sciences Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street Rasht Guilan Iran (Islamic Republic of)