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IRCT20200411047035N1 IRCT 2020-09-10 Esfahan University of Medical Sciences Comparison of the effect of fluid therapy on plasma sodium and plasma glucose levels during and after neonatal surgery Evaluation of the effect of using two methods of fluid therapy with normal saline and one-fifth-four-fifth serum on plasma sodium and plasma glucose levels during and after neonatal surgery 2020-08-31 anticipated 72 Complete https://irct.ir/trial/47076 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two groups of 36 using block randomization method of block size 4. So that four patients are randomly selected in the first block, then two of them will be simple randomly assigned to the control and the other two ones assigned to the intervention group. Again, another four patients will be randomly selected in the second block and two of them will be simple randomly assigned to the control and the other two ones assigned to the intervention group. This selection of blocks and assignment will be continued for 18 times to make the control or intervention groups of 36 ones, Blinding description: In this study, normal saline and one-fifth-four-fifth serum are prepared by the pharmacist and placed in coded packages and delivered daily to an anesthesiologist. They also prescribe them without knowing the type of any of the drugs. Also, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention. 3 Pediatric surgery. Intervention 1: All patients undergo general anesthesia in the same way and after intubation with the appropriate size and maintenance anesthesia with oxygen and Isoflurane anesthesia will be performed. Then, patients in the first intervention group will receive fluid therapy with normal saline (10 cc/kg). Intervention 2: All patients undergo general anesthesia in the same way and after intubation with the appropriate size and maintenance anesthesia with oxygen and Isoflurane anesthesia will be performed. Then, patients in the second intervention group will receive fluid therapy with one-fifth-four-fifth serum (10 cc/kg). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Amir Shafa
Imam Khomeini Street
Esfahan Iran (Islamic Republic of) 8195163381 +98 31 3886 9141 shafa_amir@yahoo.com Esfahan University of Medical Sciences scientific Dr Amir Shafa
Imam Khomeini street
Esfahan Iran (Islamic Republic of) 8195163381 +98 31 3886 9141 Shafa_amir@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Babies 1 to 30 days old Candidate for surgery with the same general anesthesia protocol American Society of Anesthesiologists Classification I and II 1 day 30 days Both Patient parents' disagreement to participate in the study Treatment - Other Treatment - Other All patients undergo general anesthesia in the same way and after intubation with the appropriate size and maintenance anesthesia with oxygen and Isoflurane anesthesia will be performed. Then, patients in the first intervention group will receive fluid therapy with normal saline (10 cc/kg). All patients undergo general anesthesia in the same way and after intubation with the appropriate size and maintenance anesthesia with oxygen and Isoflurane anesthesia will be performed. Then, patients in the second intervention group will receive fluid therapy with one-fifth-four-fifth serum (10 cc/kg) Plasma sodiun levels. Timepoint: Sodium serum before entering the operating room and immediately after entering the neonatal intensive care unit and 2 hours after entering the intensive care unit. Method of measurement: Blood test. Plasma glucose level. Timepoint: Blood sugar levels during baseline, every half hour during and after surgery, and immediately after entering the neonatal intensive care unit and 2 hours after entering the ward. Method of measurement: Glucometer device. Esfahan University of Medical Sciences Approved 2020-03-05 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib street Esfahan Isfehan Iran (Islamic Republic of)