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IRCT20200825048515N69 IRCT 2023-06-18 Esfahan University of Medical Sciences The effect of using three anesthesia methods with propofol, sevoflurane, and dexmedetomidine on respiratory complications in children aged 1 month to 3 years undergoing fiber optic bronchoscopy. Comparative study of the effect of using three anesthesia methods with propofol, sevoflurane, and dexmedetomidine on respiratory complications in children aged 1 month to 3 years undergoing fiber optic bronchoscopy. 2023-07-21 anticipated 120 Complete https://irct.ir/trial/70703 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 120 eligible children are randomly selected. For this, the letter A is written on 40 sheets, the letter B is written on 40 sheets, the letter C is written on 40 sheets, and each of them is placed in an envelope. Each Parents of patients is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of three groups, Blinding description: In order to achieve the triple-blind study, three drugs, propofol, sevoflurane, and dexmedetomidine will be prepared daily by the operating room nurse (without the researcher's awareness) and placed in the bag and will be labeled A, B, and C. And is given daily to the anesthesiologist (researcher). Therefore, the patient, the Investigator, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention. 2 Fiber optic bronchoscopy. Intervention 1: First intervention group: patients in this group are under anesthesia with inhaled sevoflurane. In this way, they are first induced with 2 MAC and after deepening the anesthesia, they receive 3.3% sevoflurane(equivalent to 1 MAC) as an anesthesia maintenance. When the patient's sedation score reaches 3, the bronchoscopist starts the procedure. Intervention 2: Second intervention group: patients in this group underwent induction of anesthesia with 1 mg/kg propofol and then they were given propofol at a dose of 0.6 mg/kg/h as anesthesia maintenance. When the patient's sedation score reaches 3, the bronchoscopist starts the procedure. Intervention 3: Third intervention group: patients in this group underwent induction of anesthesia with dexmedetomidine at a dose of 1µg/kg, and dexmedetomidine at a dose of 1µg/kg/h is used as anesthesia maintenance. When the patient's sedation score reaches 3, the bronchoscopist starts the procedure. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Amir Shafa
Department of Anesthesiology; Imam Hossein Hospital; Imam Khomeini street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 shafa_amir@yahoo.com Esfahan University of Medical Sciences scientific Amir Shafa
Department of Anesthesiology; Imam Hossein Hospital; Imam Khomeini street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 shafa_amir@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Children from 1 month to 3 years Candidate for diagnostic fiber optic bronchoscopy ASA equal to I or II Consent to participate in the study 1 month 3 years Both Having comorbidity (Such as heart disease, metabolic disease, history of seizures, high ICP, porphyria, thyroid disease) Therapeutic bronchoscopy (presence of foreign body, etc.) Treatment - Drugs Treatment - Drugs Treatment - Drugs First intervention group: patients in this group are under anesthesia with inhaled sevoflurane. In this way, they are first induced with 2 MAC and after deepening the anesthesia, they receive 3.3% sevoflurane(equivalent to 1 MAC) as an anesthesia maintenance. When the patient's sedation score reaches 3, the bronchoscopist starts the procedure. Second intervention group: patients in this group underwent induction of anesthesia with 1 mg/kg propofol and then they were given propofol at a dose of 0.6 mg/kg/h as anesthesia maintenance. When the patient's sedation score reaches 3, the bronchoscopist starts the procedure. Third intervention group: patients in this group underwent induction of anesthesia with dexmedetomidine at a dose of 1µg/kg, and dexmedetomidine at a dose of 1µg/kg/h is used as anesthesia maintenance. When the patient's sedation score reaches 3, the bronchoscopist starts the procedure. Blood pressure. Timepoint: upon entering the operating room, and every 5 minutes during bronchoscopy and every 15 minutes during recovery until the end of recovery. Method of measurement: Monitoring device. Heart beat. Timepoint: upon entering the operating room, and every 5 minutes during bronchoscopy and every 15 minutes during recovery until the end of recovery. Method of measurement: Monitoring device. Oxygen saturation (SpO2). Timepoint: upon entering the operating room, and every 5 minutes during bronchoscopy and every 15 minutes during recovery until the end of recovery. Method of measurement: Monitoring device. Respiratory complications. Timepoint: During bronchoscopy. Method of measurement: Observation. Isfahan University of Medical Sciences Approved 2023-04-15 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)