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IRCT20220523054970N1 IRCT 2023-03-29 Iran University of Medical Sciences Comparison of administration of oral dextrose with intravenous infusion of 1/3 2/3 serum, on the incidence of hypoglycemia Comparison of administration of oral dextrose with intravenous infusion of 1/3 2/3 serum, on the incidence of hypoglycemia in children 2-6 years old candidate for minor surgery under general anesthesia 2019-09-23 anticipated 66 Complete https://irct.ir/trial/63856 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Other design features: No study has been conducted in this field in Iran, Randomization description: In this intervention study, which was conducted as a randomized clinical trial, the study subjects were selected based on a simple random table. To use the table of random numbers, we first defined the framework of our statistical society; That is, the exact number of people in the society was known and they were assigned a code respectively. To select sample people from the table, it was randomly started from a point of the table in the direction of row or column. The selected number was actually the code of an individual from the community that is selected as a sample, Blinding description: The anesthetic technicians of the patients who checked their blood sugar and then the note were unaware of the type of intervention. Patients also did not understand the type of clinical intervention due to their young age. N/A Hypoglycemia. Intervention 1: The first intervention group: included patients who were fasting after midnight for surgery the next morning, and during the fasting period, maintenance 1/3 2/3 serum was calculated at 5 ml/kg per hour and was infused until the time of surgery. Intervention 2: Intervention group: The second intervention group: this group included patients who received oral 5% glucose 10 ml/kg two hours before surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the confidentiality of patients
public Mansour Gholami
یوسف اباد-میدان سلماس-خیابان شهریار-خیابان 12-پلاک 116-طبقه 5
Tehran Iran (Islamic Republic of) 1431735676 +98 916 305 3296 Mansourgh@rocketmail.com Iran University of Medical Sciences scientific Mansour Gholami
Yousef Abad, Salmas Sq., Shahriar St., 12th St., No. 116, 5th floor
Tehran Iran (Islamic Republic of) 1431735676 +98 21 8863 0346 Mansourgh@rocketmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Children 2-6 years old, candidate for minor surgery under general anesthesia 2 years 6 years Both Diabetic patients Patients with a history of hypoglycemia Metabolic diseases History of seizures E16.2 Hypoglycaemia, unspecified Other Other The first intervention group: included patients who were fasting after midnight for surgery the next morning, and during the fasting period, maintenance 1/3 2/3 serum was calculated at 5 ml/kg per hour and was infused until the time of surgery. Intervention group: The second intervention group: this group included patients who received oral 5% glucose 10 ml/kg two hours before surgery. Reducing the incidence of hypoglycemia and its complications. Timepoint: The blood glucose was checked first after the induction and the second blood glucose was checked after 30 minutes of induction. Method of measurement: Blood glucose was measured using a glucometer sensor. Hypoglycemia was defined as blood glucose less than 50 mg / kg and hyperglycemia was defined as blood glucose above 150 mg / dl. Timepoint: The blood glucose was checked first after the induction and the second blood glucose was checked after 30 minutes of induction. Method of measurement: Blood glucose was measured using a glucometer sensor. Hemodynamics including heart rate, systolic blood pressure and mean arterial pressure (MAP). Timepoint: before induction of anesthesia and every 5 minutes to 20 minutes thereafter. Method of measurement: Based on blood pressure cuff. Iran University of Medical Sciences Approved 2019-11-19 Ethics committee of Iran University of Medical Sciences Tehran Hemat Highway next to Milad Tower، 14535 Tehran Tehran Iran (Islamic Republic of)