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IRCT20190114042358N1 IRCT 2019-02-25 Tabriz University of Medical Sciences Comparing of recovery in total intravenous anesthesia(TIVA) with inhalation anaesthetic (sevoflurane) in children Comparing of recovery in total intravenous anesthesia(TIVA) with inhalation anaesthetic (sevoflurane) in children between 2-10 years old 2019-02-20 anticipated 80 Complete https://irct.ir/trial/36856 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random method: Block, Random unit: individual, Random Tool: Random Block 4. for this purpose, 25 blocks with 4 subjects in each block will be used. the combination of all patterns will be considered including AABB, ABAB, BABA, BBAA, BABA, BAAB. For selecting each blocks, dice drooped and the block number will be selected. this procedure continued to completed the allocation and reached to sample size, Blinding description: This is a double-blinded study and Researcher and patients are kept unaware of intervention in each group and In order to allocation concealment, the type of intervention will be written on paper and placed in numbered, matte and packed envelopes.The envelopes will be opened in the order of participation of the participants and the type of group will be determined. 2-3 Condition 1: inhalation anesthesia. Condition 2: Intravenous Anesthesia. Intervention 1: "Intervention group:" Total Intravenous Anesthesia.received midazolam (0/03-0/05 mg/kg), Fentanyl 1µg/kg as a premedication. Anesthesia induction will be with Lidocaine 1mg / kg and propofol 3-5 mg / kg , Then LMA will be inserted with the right size. Anesthesia maintenance with total Intravenous Anesthesia is done by infusion of propofol 100-200 mcg / kg and remifentanil 0.1 mcg / kg, 50% N2O, 50% O2. Intervention 2: "Intervention group2:" Inhalation anesthesia with sevoflurane. received midazolam (0/03-0/05 mg/kg), Fentanyl 1µg/kg as a premedication. . Anesthesia induction will be with Sevoflurane 8% , 50% N2O, 50% O2 .LMA will be inserted with the right size. Anesthesia maintenance will be with Sevoflurane inhalation 2-3% , 50% N2O, 50% O2. Yes - There is a plan to make this available What will be shared: A portion of the data that represents the final outcome When: Access will be 6 months after the results are printed. To whom: All Physicians and residents of the department of Anesthesia Conditions: After obtaining permission from the deputy research of group Where to obtain: Person responsible for scientific accountability of study How to obtain: First approved by the Research Vice-President Comments:
public Daryoush Sheikhzadeh
Tabriz Children's Hospital, Sheshgelan St
Tabriz Iran (Islamic Republic of) 5136735886 +98 41 3526 2255 dr.d.sheik@gmail.com Tabriz University of Medical Sciences scientific Daryoush Sheikhzadeh
Tabriz Children's Hospital, Sheshgelan S
Tabriz Iran (Islamic Republic of) 5136735886 +98 41 3526 2255 dr.d.sheik@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) children between 2-10 years old Indicative Outpatient Surgery Admitted to the Children's Hospital Parental informed consent for the study ASA class I and II 2 years 10 years Both Sensitivity to any of the drugs used in the study Children with underlying illnesses such as diabetes; asthma; congenital heart disease and ... Y48.0 Y48.1 Inhaled anaesthetics Parenteral anaesthetics Treatment - Drugs Treatment - Drugs "Intervention group:" Total Intravenous Anesthesia.received midazolam (0/03-0/05 mg/kg), Fentanyl 1µg/kg as a premedication. Anesthesia induction will be with Lidocaine 1mg / kg and propofol 3-5 mg / kg , Then LMA will be inserted with the right size. Anesthesia maintenance with total Intravenous Anesthesia is done by infusion of propofol 100-200 mcg / kg and remifentanil 0.1 mcg / kg, 50% N2O, 50% O2 "Intervention group2:" Inhalation anesthesia with sevoflurane. received midazolam (0/03-0/05 mg/kg), Fentanyl 1µg/kg as a premedication. . Anesthesia induction will be with Sevoflurane 8% , 50% N2O, 50% O2 .LMA will be inserted with the right size. Anesthesia maintenance will be with Sevoflurane inhalation 2-3% , 50% N2O, 50% O2 Duration of stay in recovery. Timepoint: After entering till release from recovery. Method of measurement: According to Alderet Score. Blood pressure. Timepoint: Every 5 minutes till release from recovery. Method of measurement: Monitor. Heart rate. Timepoint: Every 5 minutes till release from recovery. Method of measurement: ECG device. Nausea. Timepoint: After entering till release from recovery. Method of measurement: Visual Analogue Scale. Pain. Timepoint: After entering till release from recovery. Method of measurement: wong - baker pain scale. Tabriz University of Medical Sciences Approved 2019-01-13 Ethic Committee of Tabriz University of Medical Sciences Tabriz University of Medical Science , Gholghasht street , Azadi street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)