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IRCT20160307026950N49 IRCT 2022-12-23 Esfahan University of Medical Sciences Investigating the effect of Lidocaine and Dexmedetomidine on Tonsillectomy Comparing the effectiveness of Lidocaine and Dexmedetomidine on the severity of immediate complications after Tonsillectomy surgery 2023-01-05 anticipated 90 Complete https://irct.ir/trial/67427 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: This is a simple randomized clinical trial in which patients enter the study groups by lottery; The medicines and placebo are placed in sealed, opaque, and similar form packets coded. Each code is also written on paper, folded, and placed inside a box. After entering the operating room, each patient takes one of the papers out of the box; The pocket with the same number is the intervention that will apply to him. This process continues till the number of patients reaches the desired one, Blinding description: This is a three-way blind clinical trial; In this way, the researcher who records the patient's symptoms is different from the person who prescribes the drug and has no knowledge of the type of drug and is blind. The analysts who analyze the data collected during the study also know the type of intervention. They don't have it in any group and they are blind. Even though the guardian of patients are included in the study, they do not know the type of intervention and are blind. 3 Tonsillectomy. Intervention 1: Intervention group A: patients 10 minutes before anesthesia, receive 1.5 mg/kg lidocaine 2% (manufactured by Aburihan company) intravenously within 10 minutes, followed by an intravenous infusion of 2% lidocaine in 20 ml of normal saline with a dose of 0.25 mg/kg/minute until the end of the operation. Then, sodium thiopental (manufactured by Elixir Company) amounting to 5 mg/kg, Cis-atracurium (manufactured by Iran Hormone Company) amounting to 0.15 mg/kg, and Fentanyl (Jahan Behold Company) amounting to 2 micrograms per kilogram of weight are used to induce anesthesia for all patients. For the continuation of anesthesia, isoflurane is used in the amount of MAC 1 (Minimum alveolar concentration). After induction of anesthesia, intubation will be done inside the chip with a tube without a cuff made by Supa company with a suitable diameter. At the end of the operation, neuromuscular blocks will be reversed with atropine (0.02 mg/kg) and neostigmine (0.04 mg/kg) and after waking up, all patients will be transferred to the post-anesthesia care unit (PACU). The patient's symptoms are measured and recorded from the beginning of anesthesia to 48 hours after recovery. Intervention 2: Intervention group B: patients 10 minutes before anesthesia, receive 1 Mg/kg Dexmedetomidine (manufactured by Exir company), followed by an intravenous infusion of Dexmedetomidine in 20 ml of normal saline with a dose of 0.5Mg/kg/minute until the end of the operation. Then, sodium thiopental (manufactured by Elixir Company) amounting to 5 mg/kg, Cis-atracurium (manufactured by Iran Hormone Company) amounting to 0.15 mg/kg, and Fentanyl (Jahan Behold Company) amounting to 2 micrograms per kilogram of weight are used to induce anesthesia for all patients. For the continuation of anesthesia, isoflurane is used in the amount of MAC 1 (Minimum alveolar concentration). After induction of anesthesia, intubation will be done inside the chip with a tube without a cuff made by Supa company with a suitable diameter. At the end of the operation, neuromuscular blocks will be reversed with atropine (0.02 mg/kg) and neostigmine (0.04 mg/kg) and after waking up, all patients will be transferred to the post-anesthesia care unit (PACU). The patient's symptoms are measured and recorded from the beginning of anesthesia to 48 hours after recovery. Intervention 3: Control group C: patients10 minutes before anesthesia, receive 20 ml of normal saline as a bolus. Then, sodium thiopental (manufactured by Elixir Company) amounting to 5 mg/kg, Cis-atracurium (manufactured by Iran Hormone Company) amounting to 0.15 mg/kg, and Fentanyl (Jahan Behold Company) amounting to 2 micrograms per kilogram of weight are used to induce anesthesia for all patients. For the continuation of anesthesia, isoflurane is used in the amount of MAC 1 (Minimum alveolar concentration). After induction of anesthesia, intubation will be done inside the chip with a tube without a cuff made by Supa company with a suitable diameter. At the end of the operation, neuromuscular blocks will be reversed with atropine (0.02 mg/kg) and neostigmine (0.04 mg/kg) and after waking up, all patients will be transferred to the post-anesthesia care unit (PACU). The patient's symptoms are measured and recorded from the beginning of anesthesia to 48 hours after recovery. 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 There is no more information
public Shima Shams
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 shimashams9776@gmail.com Esfahan University of Medical Sciences scientific Behzad Nazem roaya
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients 4 to 12 years old Anesthesia class I and II according to ASA criteria Candidate for tonsillectomy surgery Informed consent to enter the study 4 years 12 years Both The presence of acute respiratory infections Abnormal coagulation tests History of allergic to drugs used J35.01 Chronic tonsillitis Prevention Prevention Placebo Intervention group A: patients 10 minutes before anesthesia, receive 1.5 mg/kg lidocaine 2% (manufactured by Aburihan company) intravenously within 10 minutes, followed by an intravenous infusion of 2% lidocaine in 20 ml of normal saline with a dose of 0.25 mg/kg/minute until the end of the operation. Then, sodium thiopental (manufactured by Elixir Company) amounting to 5 mg/kg, Cis-atracurium (manufactured by Iran Hormone Company) amounting to 0.15 mg/kg, and Fentanyl (Jahan Behold Company) amounting to 2 micrograms per kilogram of weight are used to induce anesthesia for all patients. For the continuation of anesthesia, isoflurane is used in the amount of MAC 1 (Minimum alveolar concentration). After induction of anesthesia, intubation will be done inside the chip with a tube without a cuff made by Supa company with a suitable diameter. At the end of the operation, neuromuscular blocks will be reversed with atropine (0.02 mg/kg) and neostigmine (0.04 mg/kg) and after waking up, all patients will be transferred to the post-anesthesia care unit (PACU). The patient's symptoms are measured and recorded from the beginning of anesthesia to 48 hours after recovery. Intervention group B: patients 10 minutes before anesthesia, receive 1 Mg/kg Dexmedetomidine (manufactured by Exir company), followed by an intravenous infusion of Dexmedetomidine in 20 ml of normal saline with a dose of 0.5Mg/kg/minute until the end of the operation. Then, sodium thiopental (manufactured by Elixir Company) amounting to 5 mg/kg, Cis-atracurium (manufactured by Iran Hormone Company) amounting to 0.15 mg/kg, and Fentanyl (Jahan Behold Company) amounting to 2 micrograms per kilogram of weight are used to induce anesthesia for all patients. For the continuation of anesthesia, isoflurane is used in the amount of MAC 1 (Minimum alveolar concentration). After induction of anesthesia, intubation will be done inside the chip with a tube without a cuff made by Supa company with a suitable diameter. At the end of the operation, neuromuscular blocks will be reversed with atropine (0.02 mg/kg) and neostigmine (0.04 mg/kg) and after waking up, all patients will be transferred to the post-anesthesia care unit (PACU). The patient's symptoms are measured and recorded from the beginning of anesthesia to 48 hours after recovery. Control group C: patients10 minutes before anesthesia, receive 20 ml of normal saline as a bolus. Then, sodium thiopental (manufactured by Elixir Company) amounting to 5 mg/kg, Cis-atracurium (manufactured by Iran Hormone Company) amounting to 0.15 mg/kg, and Fentanyl (Jahan Behold Company) amounting to 2 micrograms per kilogram of weight are used to induce anesthesia for all patients. For the continuation of anesthesia, isoflurane is used in the amount of MAC 1 (Minimum alveolar concentration). After induction of anesthesia, intubation will be done inside the chip with a tube without a cuff made by Supa company with a suitable diameter. At the end of the operation, neuromuscular blocks will be reversed with atropine (0.02 mg/kg) and neostigmine (0.04 mg/kg) and after waking up, all patients will be transferred to the post-anesthesia care unit (PACU). The patient's symptoms are measured and recorded from the beginning of anesthesia to 48 hours after recovery. Bleeding rate. Timepoint: From the start of surgery to 6 hours after surgery. Method of measurement: Based on the examination of the number, weight and percentage of blood gases and the amount of blood in the suction device. Laryngospasm. Timepoint: During the first two hours after the operation. Method of measurement: Based on the observation of signs of acute respiratory obstruction. Laryngitis. Timepoint: In the first 24 hours after the operation. Method of measurement: Based on the observation of hoarseness and snoring. Esfahan University of Medical Sciences Approved 2022-10-15 Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)