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IRCT20100527004041N23 IRCT 2021-07-25 Tabriz University of Medical Sciences Comparison of maintenance anesthesia with isoflurane or sevoflurane in neonates and infants during surgery Comparison of anesthesia maintenance with Isoflurane or Sevoflurane with Laryngeal mask during minor surgery in newborns and infants 2021-09-23 anticipated 68 Complete https://irct.ir/trial/57672 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using a random number table that includes numbers from 1 to 68. With each refers until the 68th patient, we create a number using the random selection system of the calculator (each number has a chance to happen only once). According to the created number, each patient is in one of the two intervention groups: 1 anesthesia with isoflurane (34 people) and the control group with anesthesia with sevoflurane (34 people). If the random number is odd, the patient places in the intervention group. If the number is even, the patient is allocated into the control group, Blinding description: In this study, 2 anesthesiologists will participate. Anesthesiologist No. 1, who will induce anesthesia in both groups, and be aware of the allocation of each patient (codes and type of anesthesia), will leave the operation room. The anesthesiologist No. 2 and the anesthesia nurse, responsible for collecting information and variables, are unaware of the type of prescription medications. They will fill the checklists during the surgery and in the recovery section. Patients (infants) and their parents are also unaware of the allocation. But the baby's parents are fully aware of the used medications in the study. 3 Comparison of hemodynamic changes after anesthesia with sevoflurane and isoflurane.. Intervention 1: Intervention group: 34 infants are placed under anesthesia with 1.5% isoflurane in a mixture of 50% oxygen and 50% N2O, and hemodynamic changes are carefully monitored. Intervention 2: Control group: 34 infants are anesthetized with 2.5% sevoflurane in a mixture of 50% O2 and 50% N2O, and hemodynamic changes are carefully monitored. Yes - There is a plan to make this available What will be shared: All potential data can be shared after making peoples unrecognizable. When: Starting 6 months after publication To whom: Documents will be available for people working in academic institutions and also people working in businesses. Conditions: There will be no specific limitations to the utilization of the data Where to obtain: Dr .Mahin Seyedhejazi, Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran ,Phone+98 413 3341994, Fax+98 41 33341994 , seidhejazie@tbzmed.ac.ir How to obtain: Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week. Comments:
public Dr. Mahin Seyedhejazi
Tabriz pediatric hospital,sheshgelan street,Tabriz
Tabriz Iran (Islamic Republic of) 5136735886 +98 41 3526 2255 seidhejazie@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Mahin Seyedhejazi
Tabriz pediatric hospital,sheshgelan street,Tabriz
Tabriz Iran (Islamic Republic of) 5136735886 +98 41 3526 2255 seidhejazie@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Infants under one year of age candidates for elective surgery less than one hour 1 day 1 year Both Requires endotracheal intubation for surgery Underlying cardiovascular disease T88.59 Other complications of anesthesia Diagnosis Diagnosis Intervention group: 34 infants are placed under anesthesia with 1.5% isoflurane in a mixture of 50% oxygen and 50% N2O, and hemodynamic changes are carefully monitored. Control group: 34 infants are anesthetized with 2.5% sevoflurane in a mixture of 50% O2 and 50% N2O, and hemodynamic changes are carefully monitored. Systolic and diastolic blood pressure. Timepoint: From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes. Method of measurement: Mercury barometer. Heart rate. Timepoint: From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes. Method of measurement: Counting in each minutes. Saturation of peripheral oxygen. Timepoint: From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes. Method of measurement: Via the Pulse Oximeter. Nausea and vomiting. Timepoint: From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes. Method of measurement: Visual Analogue Scale. Tabriz University of Medical Sciences Approved 2021-06-09 Ethic Committee of Tabriz University of Medical Sciences Vice chancellor for research, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)