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IRCT20180416039326N21 IRCT 2022-06-01 Esfahan University of Medical Sciences The effect of adding Ketamine to Dxmedetomidine and Propofol on the sedative quality and hemodynamic response in Children during Upper Gastrointestinal Endoscopy Comparison of the effect of adding low doses of Ketamine to Dxmedetomidine and Propofol on the sedative quality and hemodynamic response in Children during Upper Gastrointestinal Endoscopy 2022-05-22 anticipated 52 Complete https://irct.ir/trial/62339 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using a random sequence generated from random allocation software, patients were enrolled individually in the two groups receiving ketamine-dexmedetomidine (DK) and ketamine-propofol (KP) were included in the study, Blinding description: The study is double blinded.Patient and researcher are unaware of patient groups and type of medication.The medications are prepared by an anesthetist who is unaware of the grouping of patients and is worn by an aluminum foil and encoded by an anesthetist.Demographic information; Sedation level. The quality of pain relief and hemodynamic variables and complications are collected by a patient who is not aware of the type of drug and patient grouping. 3 Anesthesia for endoscopy. Intervention 1: Intervention group: In dexmedetomidine group (Dk), patients will receive 1-0. 7 micrograms per kilogram of dexmedetomidine and then bolus ketamine 0.4 mg per kilogram in 50 ml of normal saline for 10 minutes followed by infusion of dexmedetomidine at 50 micrograms per kilogram per hour and ketamine 0.4 micrograms per kilogram per hour. Intervention 2: Intervention group: In Propofol group (kp), patients will receive 100-50 micrograms per kilogram of Propofol and then bolus ketamine 0.4 mg per kilogram in 30 ml of normal saline for 10 minutes followed by infusion of Propofol at 50 micrograms per kilogram per hour and ketamine 0.4 micrograms per kilogram per hour. Yes - There is a plan to make this available What will be shared: Unidentifiable individual data of participants including hemodynamic indicators and complications can be shared in all two groups. When: 6 month after publication of paper To whom: Academic and medical researcher Conditions: Use for research and treatment purpose Where to obtain: Email of person in charge of public accountability ,Dr Hamidreza Shetabi: hamidshetabi@med.mui.ac.ir How to obtain: After the request, it will be sent by email, if possible, within a maximum of one month. Comments:
public Hamidreza Shetabi
Feyz hospital, Modares St
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Hamidreza Shetabi
Feiz hospital, Modarres st
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 Hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Consent of the patient or parents to participate in the study Patients aged 2 to 12 years 2 years 12 years Both ventricular atrial block (Grade 2 or 3 ) in electrocardiography Slow heart rate QTc more than 550 Millisecondon electrocardiography Severe heart failure low blood pressure (systolic blood pressure less than 90 mmHg or diastolic blood pressure less than 60 mmHg) Liver disease Use of any analgesic drug (due to possible drug interactions with the two drugs used in the study and the possibility of influencing the conclusion and prejudice of anesthesia) History of any allergy to the drug used in the design (dexmedetomidine and propofol) Treatment - Drugs Treatment - Drugs Intervention group: In dexmedetomidine group (Dk), patients will receive 1-0. 7 micrograms per kilogram of dexmedetomidine and then bolus ketamine 0.4 mg per kilogram in 50 ml of normal saline for 10 minutes followed by infusion of dexmedetomidine at 50 micrograms per kilogram per hour and ketamine 0.4 micrograms per kilogram per hour. Intervention group: In Propofol group (kp), patients will receive 100-50 micrograms per kilogram of Propofol and then bolus ketamine 0.4 mg per kilogram in 30 ml of normal saline for 10 minutes followed by infusion of Propofol at 50 micrograms per kilogram per hour and ketamine 0.4 micrograms per kilogram per hour. Sedation depth. Timepoint: Every 5 minutes during procedure and every 10 minutes in recovery. Method of measurement: Ramsey Sedation criteria. Blood pressure. Timepoint: Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: Blood pressure barometer. Heart rate. Timepoint: Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: Pulse oximeter. Recovery time. Timepoint: After completing the intervention until the withdrawal from the recovery. Method of measurement: Minute Numbers. Surgery time. Timepoint: From the beginning of the surgery. Method of measurement: Minute Numbers. Duration of anesthesia. Timepoint: From the time of anesthesia injection to the time of consciousness. Method of measurement: Minute Numbers. Complications (bradycardia, apnea). Timepoint: Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: Monitoring. Incidence of complications in recovery. Timepoint: Every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: Patient monitoring and observation. Isfahan University of Medical Sciences Approved 2021-12-11 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of medical sciences, Hezar Jarib Street Isfahan Isfehan Iran (Islamic Republic of)