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IRCT20161205031252N12 IRCT 2020-02-06 Ghoum University of Medical Sciences Comparative study on the sedative effect of ketamine, magnesium sulfate and propofol in endoscopy Comparative study on the sedative effect of ketamine, magnesium sulfate and propofol in upper endoscopy 2020-01-17 anticipated 201 Complete https://irct.ir/trial/45057 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be assigned to three groups of interventions by block randomization. For this purpose blocks of size 6 will be used. 34 blocks will include. To hide the random allocation, the numbered dark envelopes will be used, in which the group name is specified in the random sequence generated. Then, according to the order of entering samples, for the first patient the envelope number one is opened and the group will be identified until the end, Blinding description: Participants and endoscopist does not know the allocation and drugs are injected into the patient by an anesthesiologist. 3 Condition 1: Diseases of upper digestive system which need endoscopy. Condition 2: Diseases of upper digestive system which need endoscopy. Intervention 1: Control group: Amp midazolam,Daroopakhsh, 0.03 mg/kg, once, intravenous, before endoscopy + Amp propofol, Daroopakhsh, 1 mg/kg, once, intravenous, before endoscopy. Intervention 2: Intervention group 1: Amp midazolam, Daroopakhsh, 0.03 mg/kg, once, intravenous, before endoscopy + Amp ketamine, Daroopakhsh, 0.5 mg/kg, once, intravenous, before endoscopy. Intervention 3: Intervention group 2: Amp midazolam, Daroopakhsh, 0.03 mg/kg once, intravenous, before endoscopy + Amp ketamine, Daroopakhsh, 0.3 mg/kg once, intravenous, before endoscopy + Amp magnesium sulfate, Daroopakhsh, 2 gr, once, intravenous, before endoscopy. No - There is not a plan to make this available Justification or reason for not sharing IPD is The data are specific to this study
public Ahmad Hormati
Gastroenterology and Hepatology Disease Research Center, Endoscopy Unit, Shahid Beheshti Hospital, Shahid Beheshti Blv, Qom
Qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2053 Hormatia@muq.ac.ir Ghoum University of Medical Sciences scientific Ahmad Hormati
Gastroenterology and Hepatology Disease Research Center, Endoscopy Unit, Shahid Beheshti Hospital, Shahid Beheshti Blv, Qom
Qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2053 hormatia@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Patients aged more than 12 years 12 years no limit Both History of allergy to medications ASA physical status classification system more than 3 K25 K22.7 Gastric ulcer Barrett's esophagus Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: Amp midazolam,Daroopakhsh, 0.03 mg/kg, once, intravenous, before endoscopy + Amp propofol, Daroopakhsh, 1 mg/kg, once, intravenous, before endoscopy Intervention group 1: Amp midazolam, Daroopakhsh, 0.03 mg/kg, once, intravenous, before endoscopy + Amp ketamine, Daroopakhsh, 0.5 mg/kg, once, intravenous, before endoscopy Intervention group 2: Amp midazolam, Daroopakhsh, 0.03 mg/kg once, intravenous, before endoscopy + Amp ketamine, Daroopakhsh, 0.3 mg/kg once, intravenous, before endoscopy + Amp magnesium sulfate, Daroopakhsh, 2 gr, once, intravenous, before endoscopy Physician's satisfaction of the adequacy of sedation for performing endoscopy. Timepoint: Immediately after completing the endoscopy. Method of measurement: Comfort score. Patient's satisfaction of the adequacy of sedation for performing endoscopy. Timepoint: Immediately after completing the endoscopy. Method of measurement: Comfort score. Sedation response score. Timepoint: Immediately after completing the endoscopy. Method of measurement: Ramsay sedation scale. Recovery time. Timepoint: At the time of leaving recovery. Method of measurement: Time recording. Ghoum University of Medical Sciences Approved 2019-11-05 Ethics Committee of Qom University of Medical Sciences No. 83, 4th alley, 1.1 alley, Safashahr Blvd Qom Ghoum Iran (Islamic Republic of)