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IRCT20220611055132N1 IRCT 2023-11-29 Tabriz University of Medical Sciences The effect of reduced clear fluid fasting time on hemodynamic status and risk of pulmonary aspiration in children Evaluating the effect of reducing preoperative clear fluid fasting time on hemodynamic status and risk of aspiration in 2-6 years old children 2023-12-06 anticipated 96 Complete https://irct.ir/trial/65249 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using a Computerized randomization with block diagram the studied patients will be divided into interventional group and control group to reduce bias.The block randomization method is designed to randomize subjects into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time. N/A In this study disease is not examined. Intervention 1: Intervention group:They will receive 4ml/kg clear fluids(water) one hour before surgical operation. Intervention 2: Control group:The patients of Control group will receive regular fasting regime. 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 The exact time of release schedule has not been determined
public Naghi Abedini
Anesthesia Department-Second Flour-Medical College-Tabriz University of Medical Science-Golgasht St-Tabriz
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3334 1994 Naghi26@yahoo.com Tabriz University of Medical Sciences scientific Naghi Abedini
Anesthesia Department-2th floor-Medical College-Tabriz university of Medical science-Golgasht St-Tabriz
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3334 1994 Naghi26@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Children between 2-6 years old Time of operation under 2hours Obtaining parents' consent 2 years 6 years Both age below 2 years and over 6 years parental dissatisfaction operations over 2 hours operations of gastrointestinal tract history of special medications history of a previous surgery history of congenital anomalies patients who undergo emergent surgeries Other Other Intervention group:They will receive 4ml/kg clear fluids(water) one hour before surgical operation Control group:The patients of Control group will receive regular fasting regime Hemodynamic statue. Timepoint: Preoperative-during surgery-post operative. Method of measurement: Non invasive monitoring of vital signs. Tabriz University of Medical Sciences Approved 2023-10-23 Ethics committee of Tabriz University of medical science Tabriz,Golshahr,Golha blvd,Omidfar alley,No.25,4th floor Tabriz East Azarbaijan Iran (Islamic Republic of)