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IRCT20160307026950N55 IRCT 2023-12-14 Esfahan University of Medical Sciences Comparison of sedative and analgesic effects of two combinations of dexmethomidine-ketamine (Ketodex) and propofol-fentanyl (Fenofol) A comparative study of the sedative and analgesic effects of two combinations of dexmethomidine-ketamine (Ketodex) and propofol-fentanyl (Fenofel) in patients undergoing endoscopic retrograde cholangiopancreatography. 2023-12-22 anticipated 120 Complete https://irct.ir/trial/74176 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done in a simple way. The samples are randomly placed in three intervention groups 1, 2 by means of random allocation software. Sampling continues until the samples in all two groups reach the set limit, Blinding description: This study is a triple blind clinical trial, before obtaining the consent to participate in the study from the patients, in addition to explaining to them that they are randomly participating in two drug groups and they will get information about the type of drugs, but in what They will not be informed if they are placed in a group, an anesthesiologist, as the person responsible for collecting data and evaluating the outcome, is not aware of the groups, nor is the statistician, who plays the role of an analyst, aware of the groups, and after receiving the results by the presenter Decoding takes place, so we can do the study in a triple blind way. 3 Analgesia and sedation in patients undergoing endoscopic retrograde cholangiopancreatography. Intervention 1: The first intervention group: received 1 μg/kg of fentanyl and 1 mg/kg of propofol in 30 seconds and then propofol injection at 2 to 4 mg/kg per hour. The second intervention group: 0.5 μg/kg of dexmedetomidine and 1 mg/kg of ketamine in 2 divided boluses of each drug, alternately in 30 seconds, and 0.5 μg/kg per hour of dexmedetomidine and ketamine with 1 to 2 will receive mg/kg per hour. Intervention 2: Intervention group: 2nd: Half microgram/kg of dexmedetomidine and 1 mg/kg of ketamine were given as a loading dose over 2 to 5 minutes as infusion, and 0.5 microgram/kg per hour of dexmedetomidine and ketamine with 1 to 2 mg/ kg per hour . 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 more information
public Sorour sadat Asayesh
Hakim Nizami St
Isfahan Iran (Islamic Republic of) 8174618731 +98 31 3627 9414 sorourasayesh@gmail.com Esfahan University of Medical Sciences scientific Azim Honarmand
Department of Anesthesiology, AL-Zahra Hospital
Isfahan Iran (Islamic Republic of) 8174675731 +98 31366855552532 honarmand@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Consent to enter the study Patients who are candidates for endoscopic retrograde cholangiopancreatography Patients with American Society of Anesthesiologists (ASA) I,II 18 years no limit Both Patients with high blood pressure, coronary heart disease and central nervous system disorders Patients with known allergies to study drugs pregnancy Airway's disease Treatment - Drugs Treatment - Drugs The first intervention group: received 1 μg/kg of fentanyl and 1 mg/kg of propofol in 30 seconds and then propofol injection at 2 to 4 mg/kg per hour. The second intervention group: 0.5 μg/kg of dexmedetomidine and 1 mg/kg of ketamine in 2 divided boluses of each drug, alternately in 30 seconds, and 0.5 μg/kg per hour of dexmedetomidine and ketamine with 1 to 2 will receive mg/kg per hour. Intervention group: 2nd: Half microgram/kg of dexmedetomidine and 1 mg/kg of ketamine were given as a loading dose over 2 to 5 minutes as infusion, and 0.5 microgram/kg per hour of dexmedetomidine and ketamine with 1 to 2 mg/ kg per hour . Sedation rate of patients. Timepoint: The base time (before the start of the intervention) and then every 15 minutes in the operating room and in the first hour of recovery every 15 minutes to 45 minutes and then in the 2nd and 4th hours after ERCP were recorded. Method of measurement: The level of patients sedation will be evaluated using the Modified Aldrete score,whose validity and reliability have been confirmed by a recent stud. Analgesia of patients. Timepoint: The base time (before the start of the intervention) and then every 15 minutes in the operating room and in the first hour of recovery every 15 minutes to 45 minutes and then in the 2nd and 4th hours after ERCP were recorded. Method of measurement: Painlessness of patients will be evaluated using the Visual Analogue Scale (VAS) whose validity and reliability have been confirmed by a recent study. Systolic blood pressure. Timepoint: The base time (before the start of the intervention) and then every 15 minutes in the operating room and in the first hour of recovery every 15 minutes to 45 minutes and then in the 2nd and 4th hours after ERCP were recorded. Method of measurement: Barometer. Diastolic blood pressure. Timepoint: The base time (before the start of the intervention) and then every 15 minutes in the operating room and in the first hour of recovery every 15 minutes to 45 minutes and then in the 2nd and 4th hours after ERCP were recorded. Method of measurement: Barometer. Pulse rate. Timepoint: The base time (before the start of the intervention) and then every 15 minutes in the operating room and in the first hour of recovery every 15 minutes to 45 minutes and then in the 2nd and 4th hours after ERCP were recorded. Method of measurement: ECG. Respiratory rate. Timepoint: The base time (before the start of the intervention) and then every 15 minutes in the operating room and in the first hour of recovery every 15 minutes to 45 minutes and then in the 2nd and 4th hours after ERCP were recorded. Method of measurement: Breaths per minute stopwatch. Oxygen saturation. Timepoint: The base time (before the start of the intervention) and then every 15 minutes in the operating room and in the first hour of recovery every 15 minutes to 45 minutes and then in the 2nd and 4th hours after ERCP were recorded. Method of measurement: Pulse oximeter. Esfahan University of Medical Sciences Approved 2023-08-08 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib street, Azadi square, Isfahan Isfahan Isfehan Iran (Islamic Republic of)