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IRCT20200515047452N1 IRCT 2020-08-23 Shahid Beheshti University of Medical Sciences The efficacy of Etomidate and Propofol in sedation induction of children undergoing gastrointestinal endoscopy Comparison the efficacy of Etomidate and Propofol in sedation induction in children undergoing upper gastrointestinal endoscopy 2020-08-05 anticipated 90 Complete https://irct.ir/trial/49943 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization is assigned to a number from one to 90, respectively, to those who were eligible for the study. Then, without prior awareness, even numbers are allocated in the intervention group and odd numbers in the control group, Blinding description: This study was conducted double-blinded: the patients (children) and the evaluator (analyzer) were not aware of the course of the intervention. Intervention under the same conditions as P and E the intervention groups. after dilution 1 mg/kg Propofol and 0.1 mg/kg Etomidate were same as color, smell and volume. N/A Complications of sedation during endoscopic procedure. Intervention 1: Intervention group 1: In this group, Propofol 1%, 1 mg / kg will be injected intravenously immediately before endoscopy. Intervention 2: Intervention group 2: In this group, Etomidate 0.2%, 0.1 mg/kg will be injected intravenously immediately before endoscopy. Yes - There is a plan to make this available What will be shared: Demographic information of intervention groups; Complications of sedation in intervention groups When: At the end of the study To whom: All of them have aimed secondary research. Conditions: For secondary research. Where to obtain: Mofid Children's Hospital affiliated to Shahid Beheshti University of Medical Sciences-anesthesia research center-Dr. Tahereh Chavoshi How to obtain: Requesting by email. Comments:
public Tahereh Chavoshi
7th Floor; Building No.2; Shahid Beheshti University of Medical Sciences; Arabi Ave; Daneshjoo Blvd; Velenjak
Tehran Iran (Islamic Republic of) 19839-63113 +98 21 2243 9781 t.chavoshi@yahoo.com Shahid Beheshti University of Medical Sciences scientific Tahereh Chavoshi
7th Floor; Building No.2; Shahid Beheshti University of Medical Sciences; Arabi Ave; Daneshjoo Blvd; Velenjak
Tehran Iran (Islamic Republic of) 19839-63113 +98 21 2243 9781 t.chavoshi@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Children at the age of 1 to 15 years old Candidate for upper gastrointestinal tract endoscopic procedure Class I & II 1 year 15 years Both History of drug allergy to Propofol or Etomidite Kidney disease Liver disease Adrenal disease Severe pneumonia ICU hospitalization History of Postoperative nausea and vomiting G6PD deficiency T81 Complications of procedures, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group 1: In this group, Propofol 1%, 1 mg / kg will be injected intravenously immediately before endoscopy. Intervention group 2: In this group, Etomidate 0.2%, 0.1 mg/kg will be injected intravenously immediately before endoscopy. Blood pressure changes. Timepoint: Immediately before anesthesia and after anesthesia (first minute, 5th minute, 10th minute and 15th minute) will be monitored and recorded. Method of measurement: Blood pressure monitorinng. Apnea (the cessation of breathing for 10 secounds). Timepoint: Continuously. Method of measurement: Observation of respiratory movements and pulse oximeter changes. Frequency of Laryngospasm (closure of the vocal cords and lack of air transfer to the lungs and vice versa). Timepoint: Continuously. Method of measurement: Observation. Duration of Laryngospasm (during time from closure of the vocal cords and lack of air transfer to the lungs and vice versa to bag valve mask ventilation). Timepoint: Continuously. Method of measurement: Cornometer. Duration of Anesthesia recovery. Timepoint: once at recovery room. Method of measurement: Cornometer. Nausea and vomiting. Timepoint: Continuously. Method of measurement: Observation. Agitation. Timepoint: After anesthesia (first minute, 5th minute, 10th minute and 15th minute) will be monitored and recorded. Method of measurement: Sedation Scale for Agitation score,. Heart rate changes. Timepoint: Immediately before anesthesia and after anesthesia (first minute, 5th minute, 10th minute and 15th minute) will be monitored and recorded. Method of measurement: puls oximetry. Respiratory rate changes. Timepoint: Immediately before anesthesia and after anesthesia (first minute, 5th minute, 10th minute and 15th minute) will be monitored and recorded. Method of measurement: Chest movement per minute. Awakening from sedation. Timepoint: Getting to recovey unit until obey the commands and communication with parents. Method of measurement: Observation. Shahid Beheshti University of Medical Sciences Approved 2020-05-11 Ethics committee of Shahid Beheshti University of Medical Sciences 7th Floor; Building No.2; Shahid Beheshti University of Medical Sciences; Arabi Ave; Daneshjoo Blvd; Velenjak Tehran Tehran Iran (Islamic Republic of)