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IRCT20171216037910N1 IRCT 2019-04-19 Sanandaj University of Medical Sciences Vitamin B6 in elective cesarean section Assessment of Pyridoxine (Vitamin B6) effects on the Nausea and Vomiting Rates in Patients candidate for Elective Cesarean Section 2019-05-05 anticipated 140 Complete https://irct.ir/trial/33470 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Balanced (permuted) block randomization( four random blocks). In each block, 4 patients are randomly assigned random codes A1, A2, A3 and B, and according to the corresponding code, they receive the dose and the desired drug or placebo, Blinding description: The normal saline serum containing medicine or placebo is prepared and coded by a nurse who is not aware of the study process. The prescriber and collaborator, who completes the relevant assessments and completes the questionnaire, is not aware of the drug or placebo received by the patient. After completion of the data collection work, analyzes will be carried out based on the relevant codes. 3 Nausea and vomiting after surgery in cesarean section with spinal anesthesia. Intervention 1: Intervention group:Prescribing vitamin B6 : 25 mg, 20 minutes before surgery (group 1). Intervention 2: Intervention group: Prescribing vitamin B6 : 50 mg, 20 minutes before surgery (group 2). Intervention 3: Intervention group: Prescribing vitamin B6 : 100 mg, 20 minutes before surgery (group 3). Intervention 4: Control group: In the control group, 500 ml of normal saline solution will be infused 20 minutes before surgery. 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 No more information
public Seyed Arvin Barzanji
Faculty of Paramedicine, Medical University of Kurdistan, Pasdaran Blvd
Sanandaj Iran (Islamic Republic of) 6614713446 +98 87 3334 2561 arvin.barzanji1988@gmail.com Sanandaj University of Medical Sciences scientific Seyed Arvin Barzanji
Faculty of Paramedicine, Medical University of Kurdistan, Pasdaran Blvd
Sanandaj Iran (Islamic Republic of) 6614713446 +98 87 3334 2561 arvin.barzanji1988@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Fasting for 8 hours before surgery candidate for elective cesarean section Patient's full health of the digestive tract Being monogamous Filling out the consent form and willingness to participate in the study 18 years 45 years Female Patients with diabetes Contraindications for spinal anesthesia or Conversion of spinal anesthesia into general anesthesia during surgery History of vertigo and vomiting during pregnancy Patients who have used anti-emetic drugs before surgery Get psychotropic or opioid drugs Patients with a BMI greater than 28 Patients with pre-eclampsia, eclampsia, hypertension, oesophageal hernia, gastroesophageal reflux disease Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group:Prescribing vitamin B6 : 25 mg, 20 minutes before surgery (group 1) Intervention group: Prescribing vitamin B6 : 50 mg, 20 minutes before surgery (group 2) Intervention group: Prescribing vitamin B6 : 100 mg, 20 minutes before surgery (group 3) Control group: In the control group, 500 ml of normal saline solution will be infused 20 minutes before surgery. Primary outcome: nausea and vomiting. Timepoint: Nausea and vomiting are investigated during surgery and recovery time, and 2, 4, 6, 12, 18, and 24 hours after surgery. Method of measurement: The BARF method is based on the BARF ruler and according to the smileys, scoring is done. 2. Qualitative method (Likert scoring criterion). The amount of anti-emetic drugs. Timepoint: In the first 24 hours after surgery. Method of measurement: Dosage and frequency of administration. Intensity of pain. Timepoint: Intensity of pain is investigated during recovery time, 2, 4, 6, 12, 18, and 24 hours after surgery. Method of measurement: Pain is measured using the visual analog scale. The length of the recovery period. Timepoint: ّIn the recovery period. Method of measurement: Based on time (hours). The length of hospitalization. Timepoint: Patient admission period. Method of measurement: Based on time (day). Sanandaj University of Medical Sciences Approved 2018-06-26 Ethics committee of Kurdistan University of Medical Sciences Faculty of Medicine, Kurdistan University of Medical Sciences, Pasdaran Blvd. Sanandaj Kurdistan Iran (Islamic Republic of)