]>
IRCT20130304012695N18 IRCT 2023-11-20 Tehran University of Medical Sciences Sedation in bronchoscopy Comparison of the sedative effects of diphenhydramine and dexmedetomidine in fiberoptic bronchoscopy of patients 2023-12-21 anticipated 70 Complete https://irct.ir/trial/73802 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize patients Block balanced randomization is used. Before studying, one of the person who is not a member of the research team performs the randomization process by using Random generator software, forms blocks with size of 4 for the intervention and control groups. The complete cards of blocks are given to the head of the operative room, who is unaware of the study process in an envelope and one card is given to each patient before starting intubation process, Blinding description: The patients participating in the research are not aware of the type of sedation for bronchoscopy. The name of the person responsible for collecting research data is not in the list of researchers. The clinical care person also does not know about the research groups. The data analyst is not involved in the research process. 1-2 Sedation for bronchoscopy. Intervention 1: Intervention group: 10 ml of normal saline containing 1 mg/kg diphenhydramine (manufactured by Raha Pharma) is prepared with the help of an anesthetist according to the patient's grouping and is infused intravenously 10 minutes before bronchoscopy. The volume of the control group is prepared from normal saline and is infused at a constant rate until the end of the procedure.During bronchoscopy and recovery, information related to the target variables of the study will be collected. If the patients are restless during the procedure, propofol (manufactured by Pfizer) will be used to improve sedation. Intervention 2: Control group: 10 ml of normal saline containing 1 µg/kg of dexmedetomidine (manufactured by Darou Darman Arang factory) is prepared with the help of an anesthesiologist according to the grouping of the patient and is infused intravenously 10 minutes before bronchoscopy. Then a syringe of the same shape and volume The intervention group was prepared with normal saline and dexmedetomidine and was infused at a rate of 0.5 µg/kg/h until the end of the operation. If the patients are restless during the procedure, propofol (manufactured by Pfizer) will be used to improve sedation. Yes - There is a plan to make this available What will be shared: Main study outcome data When: Six months after the end of the study To whom: University and industry researchers Conditions: Sharing experiences to increase the sedation of bronchoscopy patients Where to obtain: Dr. Khajavi's email address is khajavim@tums.ac.ir How to obtain: Request by email and response within one month Comments:
public Mohammadreza Khajavi
Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 1220 khajavim@tums.ac.ir Tehran University of Medical Sciences scientific Mohammadreza Khajavi
Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 1220 khajavim@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) All candidates for fiberoptic bronchoscopy aged 20-70 years who need sedation 20 years 70 years Both Patients who have a history of drug addiction or are taking methadone Patients who take neurologic or psychoactive drugs Patients with a history of renal and liver failure History of allergy to diphenhydramine History of ischemic heart disease Patients with hemodynamic instability Treatment - Drugs Treatment - Drugs Intervention group: 10 ml of normal saline containing 1 mg/kg diphenhydramine (manufactured by Raha Pharma) is prepared with the help of an anesthetist according to the patient's grouping and is infused intravenously 10 minutes before bronchoscopy. The volume of the control group is prepared from normal saline and is infused at a constant rate until the end of the procedure.During bronchoscopy and recovery, information related to the target variables of the study will be collected. If the patients are restless during the procedure, propofol (manufactured by Pfizer) will be used to improve sedation. Control group: 10 ml of normal saline containing 1 µg/kg of dexmedetomidine (manufactured by Darou Darman Arang factory) is prepared with the help of an anesthesiologist according to the grouping of the patient and is infused intravenously 10 minutes before bronchoscopy. Then a syringe of the same shape and volume The intervention group was prepared with normal saline and dexmedetomidine and was infused at a rate of 0.5 µg/kg/h until the end of the operation. If the patients are restless during the procedure, propofol (manufactured by Pfizer) will be used to improve sedation. The degree of sedation and agitation. Timepoint: At the beginning and 2, 5, 10 and 15 minutes of bronchoscopy. Method of measurement: Based on the criteria of the Richmond Agitation Sedation Scale. Amount of propofol boluses in cases of insufficient sedation. Timepoint: Agitation degree greater than one during bronchoscopy. Method of measurement: At the end of bronchoscopy based on mg. Hemodynamic indicators ,heart rate and blood pressure. Timepoint: Before drug induction and 5, 10 and 15 minutes after starting bronchoscopy and during recovery. Method of measurement: From patient monitoring. Hypoxemia. Timepoint: During bronchoscopy. Method of measurement: By pulse oximetry. Recovery time. Timepoint: From the end of bronchoscopy to the time of leaving the bronchoscopy department. Method of measurement: By the Chronometer based on minutes. Tehran University of Medical Sciences Approved 2023-11-12 Research Ethics Committee of Sina Hospital - Tehran University of Medical Sciences Sina Sospital, Imam Khomeini st. Tehran Tehran Iran (Islamic Republic of)