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IRCT20120915010841N16 IRCT 2019-04-24 Hamedan University of Medical Sciences Efficacy of intravenous lidocaine 2% and propofol in preventing laryngospasm The comparative Evaluation of Efficacy of intravenous lidocaine 2% and propofol in preventing laryngospasm and complications after tonsilectomy 2019-04-09 anticipated 102 Complete https://irct.ir/trial/38697 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: we provide ten paper sheets . We write five letters A and on five other sheets of letter B. We mix the papers together and put them in the drawer of the table.With each of the qualified patients, one of the papers is taken out randomly and, According to the text, the patient is given one of two groups: A (Propofol) and B (Lidocaine). Then, for ten subsequent patients, the paper is returned to the bag again, and this process is repeated until the end of the sample volume, Blinding description: In both groups A and B, medications (propofol or lidocaine) will be prescribed two minutes before the extubation of the chip. In order to prevent the medication being detectable for patients and investigators, they are prepared and injected into syringes of the same size and shape and on the adhesives A and B by the anesthetist. Since drugs are prescribed and prescribed by an anesthetist, the clinician will not be aware of the type of prescribed medication that will measure and record the outcome of the study. 2 laryngospasm and complications after tonsilectomy. Intervention 1: Intervention group: Children aged 3 to 14 years old are candidates for adenotonsillectomy, which will receive 1 mg / kg of lidocaine 2%, two minutes before extubation. Intervention 2: Intervention group: Children aged 3 to 14 years old are candidates for adenotonsillectomy, which will receive 0.5 mg / kg propofol two minutes before to extubation. 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
Pasdaran Street
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3827 7012 manuchehriann@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Aged 3-14 years old Candidate for elective adenotonsilectomy Parental Satisfaction 3 years 14 years Both Those who are reluctant to continue to participate in the study History of Cardio-pulmonary disease Recent infection of the upper respiratory tract and febrile illnesses History of allergy to eggs, soy, lidocaine and propofol difficult intubation Corticosteroid use J38.5 Laryngeal spasm Prevention Prevention Intervention group: Children aged 3 to 14 years old are candidates for adenotonsillectomy, which will receive 1 mg / kg of lidocaine 2%, two minutes before extubation. Intervention group: Children aged 3 to 14 years old are candidates for adenotonsillectomy, which will receive 0.5 mg / kg propofol two minutes before to extubation. Laryngospasm. Timepoint: 1, 3, 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. Hamedan University of Medical Sciences Approved 2018-12-01 Ethics Committee of Hamadan university of medical sciences Mahdieh Street Hamadan Hamadan Iran (Islamic Republic of)