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IRCT20200506047322N1 IRCT 2020-07-31 Esfahan University of Medical Sciences Effect of intravenous lidocaine and intravenous dexamethasone on respiratory complications after adeno-tonsillectomy surgery Evaluation of the effect of intravenous lidocaine and intravenous dexamethasone on respiratory complications after adeno-tonsillectomy surgery and comparison with control group 2018-10-17 anticipated 90 Complete https://irct.ir/trial/48604 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants in the present study were coded. Codes enter Random Allocation Software and divide by randomly blocking method into 2 groups of intervention and the control group with senary blocks and a ratio of 1:1 . In order to conceal the allocation; The groups were placed in similar envelopes in a matte package numbered consecutively. Blocking and preparation of envelopes was performed by a person who is not involved in sampling and data analysis, Blinding description: Patients have no information about the medication they receive.The information enters the software with the code and the analyst is unaware of the allocation of groups. After finishing and analyzing the data, the codes are opened. 3 adeno-tonsillectomy. Intervention 1: Intervention group 1: Lidocaine intravenous infusion of 1.5 mg / kg in 15 cc normal saline within 10 minutes. Intervention 2: Intervention group 2: Dexamethasone intravenous infusion 0.2 mg / kg in 15 cc normal saline within 10 min. Intervention 3: Control group: without any drug. No - There is not a plan to make this available Justification or reason for not sharing IPD is The information belongs to the government agency.
public Kamran Montazeri
Hezar jarip Street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3669 2174 montazeri@med.mui.ac.ir Esfahan University of Medical Sciences scientific Kamran Montazeri
Hezar jarip Street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3669 2174 montazeri@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) All patients are candidates for adeno-tonsillectomy surgery with an age range of 4-14 years and anesthesia ASA 1 or 2 4 years 14 years Both Active upper respiratory tract infection within two weeks prior to surgery Active infection of the lower respiratory tract during 5 weeks before surgery A history of asthma History of sensitivity to lidocaine and history of sensitivity to dexamethasone Smoking patient J35 Chronic diseases of tonsils and adenoids Prevention Prevention Other Intervention group 1: Lidocaine intravenous infusion of 1.5 mg / kg in 15 cc normal saline within 10 minutes Intervention group 2: Dexamethasone intravenous infusion 0.2 mg / kg in 15 cc normal saline within 10 min Control group: without any drug Respiratory complications. Timepoint: Up to 15 minutes per minute after injection of the drug and then every 15 minutes until discharge from recovery. Method of measurement: Airway Irritability Rating Score. Hemodynamic disorders. Timepoint: Up to 15 minutes per minute after injection of the drug and then every 15 minutes until discharge from recovery. Method of measurement: pulse oximeter. Recovery time. Timepoint: From the beginning of the drug injection to the end of recovery. Method of measurement: Measuring time (minutes ). Esfahan University of Medical Sciences Approved 2020-04-29 Ethics Committee of Isfahan University of Medical Sciences Hezar Jarib street Isfahan Isfehan Iran (Islamic Republic of)