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IRCT20230506058100N1 IRCT 2023-06-14 Iran University of Medical Sciences The incidence of rigid bronchoscopy complications in children with foreign body aspiration Comparison of the incidence of rigid bronchoscopy complications with three anesthesia methods of spontaneous ventilation, controlled ventilation using Atracurium and controlled ventilation using Rocuronium in children with foreign body aspiration 2023-04-30 anticipated 63 Complete https://irct.ir/trial/70038 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method with block size 4 is used. The website https://www.sealedenvelope.com is used to generate random sequences. Each of the randomly generated sequences contains a unique code for concealment. The randomized list is provided to one of the operating room personnel and he tells the researcher which group each patient should be placed in. Then the patients are assigned to 3 groups, Blinding description: Patient blinding: Patients are unaware of the treatment process due to their condition and they are unconscious. Care giver blinding: in 3 groups, Propofol will be drawn into a syringe and connected to the infusion pump, but it will be injected only in the Propofol group. Propofol is distilled water, and in Rocuronium and Atracurium groups, the dose of the corresponding drug is the same, so it is not possible for the assistant data recorder and the person performing the bronchoscopy to distinguish the Propofol group from the other two groups. 3 Foreign body aspiration. Intervention 1: Group P or Propofol : After induction of inhalation anesthesia with Sevoflurane, Propofol infusion is started at a dose of 80-100 mcg/kg/min, and the relaxant drug will not be injected, and after 3 minutes, rigid bronchoscopy is started. In this group, assisted breathing is given by controlling the ambobag and chest movements, and after the procedure, the drugs are removed. Intervention 2: Group R or Rocuronium: after induction of inhalation anesthesia with Sevoflurane, Rocuronium is injected at a dose of 0.3 mg/kg and bronchoscopy is started after 3 minutes, Propofol infusion is not performed in this group, and the oxygen line is connected through an interface next to the bronchoscope (T segment), and controlled breathing is given with an ambobag through the Mepleson D system. If the procedure is prolonged, and need to repeat the relaxant Rocuronium is prescribed at a dose of 0.2 mg /kg and 0.3 mg /kg. After the procedure, breathing with a face mask and oxygen and low dose Sevoflurane (1%) continues until the patient's breathing returns, and then Sevoflurane is stopped and reversed with Atropine 0.02 mg /kg and Neostigmine 0.05 mg/kg. Intervention 3: Group A or Atracurium: after induction of inhalation anesthesia with Sevoflurane, Atracurium is injected at a dose of 0.3 mg/kg and after 3 minutes' bronchoscopy is started. Propofol infusion is not performed in this group, and the oxygen line is connected through an interface next to the bronchoscope (T segment), and controlled breathing is given with an ambobag through the Mepleson D system. If the procedure is prolonged need to repeat the relaxant drug, Atracurium is prescribed at a dose of 0.2 and 0.3 mg /kg. After the procedure, breathing with a face mask and oxygen and low dose Sevoflurane (1%) continues until the patient's breathing returns, and then Sevoflurane is stopped and reversed with Atropine 0.02 mg /kg and neostigmine 0.05 mg/kg is done. 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 further information
public Tahereh Chavoshi
No.193, Zafar st, Moddares Highway
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6253 Chavoshi.t@iums.ac.ir Iran University of Medical Sciences scientific Tahereh Chavoshi
No.193, Zafar st, Moddares Highway
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6253 Chavoshi.t@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Parents' consent to participate in the study after bronchoscopy Age range 1 to 6 years Children with foreign body aspiration , if the foreign body is not in the upper part of the main airway and in the larynx or hypopharynx They should be in ASA class 1 and 2 1 year 6 years Both Emergency cases Children with asthma and irritable airways Airway anomaly Drug allergy to any of the drugs used Neurological disorders and seizures kidney disease Cardiovascular disease Neuromuscular disorder Metabolic disorder T17.9 Foreign body in respiratory tract, part unspecified Treatment - Surgery Treatment - Surgery Treatment - Surgery Group P or Propofol : After induction of inhalation anesthesia with Sevoflurane, Propofol infusion is started at a dose of 80-100 mcg/kg/min, and the relaxant drug will not be injected, and after 3 minutes, rigid bronchoscopy is started. In this group, assisted breathing is given by controlling the ambobag and chest movements, and after the procedure, the drugs are removed. Group R or Rocuronium: after induction of inhalation anesthesia with Sevoflurane, Rocuronium is injected at a dose of 0.3 mg/kg and bronchoscopy is started after 3 minutes, Propofol infusion is not performed in this group, and the oxygen line is connected through an interface next to the bronchoscope (T segment), and controlled breathing is given with an ambobag through the Mepleson D system. If the procedure is prolonged, and need to repeat the relaxant Rocuronium is prescribed at a dose of 0.2 mg /kg and 0.3 mg /kg. After the procedure, breathing with a face mask and oxygen and low dose Sevoflurane (1%) continues until the patient's breathing returns, and then Sevoflurane is stopped and reversed with Atropine 0.02 mg /kg and Neostigmine 0.05 mg/kg. Group A or Atracurium: after induction of inhalation anesthesia with Sevoflurane, Atracurium is injected at a dose of 0.3 mg/kg and after 3 minutes' bronchoscopy is started. Propofol infusion is not performed in this group, and the oxygen line is connected through an interface next to the bronchoscope (T segment), and controlled breathing is given with an ambobag through the Mepleson D system. If the procedure is prolonged need to repeat the relaxant drug, Atracurium is prescribed at a dose of 0.2 and 0.3 mg /kg. After the procedure, breathing with a face mask and oxygen and low dose Sevoflurane (1%) continues until the patient's breathing returns, and then Sevoflurane is stopped and reversed with Atropine 0.02 mg /kg and neostigmine 0.05 mg/kg is done. Laryngospasm. Timepoint: beginning of bronchoscopy to end of anesthesia and the patient waking up. Method of measurement: Decreased oxygen saturation following epiglottis closure. Iran University of Medical Sciences Approved 2023-04-17 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences; Next to the Milad Tower; Hemmat Highway Tehran Tehran Iran (Islamic Republic of)