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IRCT20201207049639N5 IRCT 2021-01-09 Oroumia University of Medical Sciences Effect of sevoflurane and propofol for laryneal mask airway insertion Comparison of sevoflurane with and without propofol for laryneal mask airway insertion in children; a double-blinded clinical trial 2020-06-22 anticipated 36 Complete https://irct.ir/trial/53331 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Candidate children for abdominal and lower limb surgery were randomly divided into two groups receiving sevoflurane with and without propofol using https://www.randomizer.at/, Blinding description: Patients were unaware of their placement in the intervention groups and the statistical analyzer received the data in code, not the actual grouping. 3 Laryneal mask airway insertion in children. Intervention 1: Intervention group: Patients in the intervention group underwent induction of anesthesia with 8% sevoflurane with oxygen and N2O in equal proportions. The criterion of anesthesia was the disappearance of the eyelid reflex. Laryngeal mask was inserted 90 second after anesthesia by skilled person. During this time, the patient received only 8% sevoflurane with oxygen and N2O in equal proportions annd 1 mg/kg propoful (Produced by ABIAN Pharmed). Intervention 2: Control group: Patients in the control group underwent induction of anesthesia with 8% sevoflurane with oxygen and N2O in equal proportions. The criterion of anesthesia was the disappearance of the eyelid reflex. Laryngeal mask was inserted 90 second after anesthesia by skilled person. During this time, the patient received only 8% sevoflurane with oxygen and N2O in equal proportions. Yes - There is a plan to make this available What will be shared: Information can be provided without patients' names When: A year after completion of the study To whom: Faculty researchers Conditions: Only for research purposes approved by a legal center as an approved project Where to obtain: Email to the scientific responsible of the project who is Dr. Hoshyar hooshyar.h@umsu.ac.ir How to obtain: One week after sending the email and checking the purpose of the request Comments:
public Dr. Hadi Hooshyar
Shahid Motahhari Hospital; Kashani street; Urmia; Iran.
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3198 8293 hooshyar.h@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Hadi Hooshyar
Shahid Motahhari Hospital; Kashani street; Urmia; Iran.
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3198 8293 hooshyar.h@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Age between 2 to 8 years old American Society of Anesthesiologists (ASA) I and II Abdominal and lower limb surgeries 2 years 8 years Both Dissatisfaction of parents to participate in the study Possibility of surgery with spinal anesthesia Treatment - Drugs Treatment - Drugs Intervention group: Patients in the intervention group underwent induction of anesthesia with 8% sevoflurane with oxygen and N2O in equal proportions. The criterion of anesthesia was the disappearance of the eyelid reflex. Laryngeal mask was inserted 90 second after anesthesia by skilled person. During this time, the patient received only 8% sevoflurane with oxygen and N2O in equal proportions annd 1 mg/kg propoful (Produced by ABIAN Pharmed). Control group: Patients in the control group underwent induction of anesthesia with 8% sevoflurane with oxygen and N2O in equal proportions. The criterion of anesthesia was the disappearance of the eyelid reflex. Laryngeal mask was inserted 90 second after anesthesia by skilled person. During this time, the patient received only 8% sevoflurane with oxygen and N2O in equal proportions. Time to reach the desired relaxation for laryngeal mask insertion. Timepoint: Due to the nature of the variable under study, which is time, only once from the time of administration of sevoflurane to the desired relaxation was considered. Method of measurement: Timer by second. Heart rate. Timepoint: Once during laryngeal mask insertion. Method of measurement: Pulsoximeter. Oroumia University of Medical Sciences Approved 2019-06-19 Ethics Committee of Urmia University of Medical Sciences Urmia University of Medical Sciences, Resalat Street, Jahad Ave., Urmia, Iran Urmia West Azarbaijan Iran (Islamic Republic of)