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IRCT20120915010841N22 IRCT 2020-01-24 Hamedan University of Medical Sciences Evaluation of Efficacy of intravenous magnesium sulphate with lidocaine 2% in preventing laryngospasm and postoperative pain after tonsilectomy The comparative Evaluation of Efficacy of intravenous magnesium sulphate with lidocaine 2% in preventing laryngospasm and postoperative pain after tonsilectomy: Double blind clinlcal trial 2019-11-01 anticipated 62 Complete https://irct.ir/trial/43578 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization as a four-block design will be used. In this way, according to the sample size,16 blocks of four are identified, and in each of these four blocks, two person of each group will be written in the form of letters A (Magnesium sulfate) or B(Lidocaine). This means that two letters A and two letters B will be written in each block, although the order of the writing of the four letters A and B will be different in each block. The random numbers table will then be used to determine the order of block selection, Blinding description: For each group A or B, one of two drugs (magnesium sulfate or lidocaine) will be prescribed after spinal anesthesia. For blinding of patients and the researcher, the syringes for both groups will be in similar size and shape with A or B labels on them. Medications will be prepared and injected by the anesthesiologist. Since the drugs will be prescribed and administered by the anesthesiologist. The assistant who will measure and record the outcome of the study will not be aware of the type of medication prescribed. 2 laryngospasm and complications after tonsilectomy. Intervention 1: Intervention group: Children 3-14 years of age candidate for adenotonsillectomy will receive 15 mg / kg magnesium sulfate in a total volume of 15 ml two minutes after intubation. Intervention 2: Intervention group: Children 3-14 years of age candidate for adenotonsillectomy will receive lidocaine 1mg / kg in a total volume of 15ml two minutes after intubation. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Because the study is not finished yet.
public Nahid Manouchehrian
Fatemieh Hospital, Pasdaran Street
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3827 7012 manuchehriann@gmail.com Hamedan University of Medical Sciences scientific Nahid Manouchehrian
Fatemieh Hospital, Pasdaran Street
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3827 7012 manuchehriann@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age 3-14 years old with ASA Class 1 & 2 Candidate for elective adenotonsillectomy Parental consent to participate in the project 3 years 14 years Both Heart, pulmonary and renal disease Recent infection of the upper respiratory tract and fever A history of allergies to magnesium sulfate, lidocaine Probability of intubation difficult Corticosteroid intake Arrhythmias and heart blocks A history of myasthenia gravis J38.5 Laryngeal spasm Treatment - Drugs Treatment - Drugs Intervention group: Children 3-14 years of age candidate for adenotonsillectomy will receive 15 mg / kg magnesium sulfate in a total volume of 15 ml two minutes after intubation. Intervention group: Children 3-14 years of age candidate for adenotonsillectomy will receive lidocaine 1mg / kg in a total volume of 15ml two minutes after intubation. Laryngospasm. Timepoint: 1, 5, 10 and 15 minutes after extubation. Method of measurement: Observation. Nausea & vomiting. Timepoint: After surgery. Method of measurement: Observation. Systolic and Diastolic Blood Pressure. Timepoint: Every two minutes for 10 minutes and then every 10 minutes to 60 minute. Method of measurement: Non-invasive automatic barometric device. Heart Rate. Timepoint: Every two minutes for 10 minutes and then every 10 minutes to 60 minute. Method of measurement: Non-invasive automatic barometric device. Sedation. Timepoint: We record ramsy sedation score in 24 hours after surgery.‎. Method of measurement: Ramsy sedation score. Hamedan University of Medical Sciences Approved 2019-06-15 Ethics Committee of Hamadan University of Medical Sciences Mahdieh Street Hamadan Hamadan Iran (Islamic Republic of)