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IRCT20191201045566N1 IRCT 2020-09-06 Ahvaz University of Medical Sciences Comparison of midazolam – propofol versus midazolam – ketamin in sedative endoscopy in out patients Comparison of midazolam – propofol versus midazolam – ketamin in sedative endoscopy in out patients since April until the end of November 2019 at the Ahvaz Imam Khomeini Hospital 2019-09-30 anticipated 78 Complete https://irct.ir/trial/43923 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple Randomization Method Individual Randomization Unit Randomization Tool: Statistical software, Blinding description: This study is a double blind study after the patient is fully aware of the research and the researcher and patient are not aware of the type of prescription drugs. 2-3 Endoscopy. Intervention 1: Intervention group: Both groups were given fentanyl at a dose of 0.5 micrograms per kilogram. In group A, midazolam was administered intravenously at a rate of 0.5 micrograms per kilogram for each patient of standard weight, followed by bolus injection of 0.7 milligrams per kilogram of propofol. If necessary, an infusion of propofol at one-third of the initial dose was used. Intervention 2: Intervention group: Fentanyl was administered at a dose of 0.5 micrograms per kilogram. In group B, ketamine at a dose of 0.5 milligrams per kilogram was injected as a bolus and midazolam at a dose of 0.5 micrograms per kilogram, if necessary. Propofol infusion was used at a rate of one third of the initial dose. Yes - There is a plan to make this available What will be shared: All potential data can be shared after unidentified individuals When: Start of access period 6 months after printing the results To whom: It will be available only to researchers working in academic and scientific institutions Conditions: For the purpose of scientific research in the field of anesthesia and in compliance with medical ethics Where to obtain: Ahvaz - University City - Ahvaz Jundishapur University of Medical Sciences - Central Library Building - First Floor - PO Box: 158 Postal Code: 15794-61357 Phone 3311-061 E-mail: info@ajums.ac.ir How to obtain: Request by e-mail from the Central Library of Jundishapur University of Medical Sciences and then check the eligibility to provide data to individuals and then the availability of data Comments:
public Dr Reza Baqbanian
Imam Khomeini Medical Center of Ahvaz, Azadegan St.
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3222 0168 baghbanian-r@ajums.ac.ir Ahvaz University of Medical Sciences scientific Dr Reza Baqbanian
Imam Khomeini Medical Center of Ahvaz, Azadegan St.
Ahvaz Iran (Islamic Republic of) 6193643166 +98 61 3222 0168 baghbanian-r@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) All endoscopic patients Age 20 to 60 years Weight 55 to 85 kg Being in ASA class one or two 20 years 60 years Both Blood pressure history Diabetes Respiratory failure Liver problem Kidney problem Addiction Heart disease Drug allergy Other Other Intervention group: Both groups were given fentanyl at a dose of 0.5 micrograms per kilogram. In group A, midazolam was administered intravenously at a rate of 0.5 micrograms per kilogram for each patient of standard weight, followed by bolus injection of 0.7 milligrams per kilogram of propofol. If necessary, an infusion of propofol at one-third of the initial dose was used Intervention group: Fentanyl was administered at a dose of 0.5 micrograms per kilogram. In group B, ketamine at a dose of 0.5 milligrams per kilogram was injected as a bolus and midazolam at a dose of 0.5 micrograms per kilogram, if necessary. Propofol infusion was used at a rate of one third of the initial dose. Sedation. Timepoint: From the moment of injection and during injection and after waking up. Method of measurement: Based on the Ramsey variable. Comparison of nausea and vomiting in two groups of midazolam - propofol with midazolam - ketamine in patients undergoing outpatient endoscopy. Timepoint: From the end of the procedure to the time of leaving the recovery. Method of measurement: Visual analoge scale. Comparison of postoperative pain in patients in two groups of midazolam-propofol with midazolam-ketamine in patients undergoing outpatient endoscopy. Timepoint: At the beginning of the procedure, the end of the procedure and one hour after the end of the procedure. Method of measurement: Ambesh score. Comparison of recovery time in patients between the two groups of midazolam-propofol with midazolam-ketamine in patients undergoing outpatient endoscopy. Timepoint: From the time the procedure was completed to the patient's alertness and appropriate response to questions, recovery time was considered (every 30 seconds, recovery was assessed). Method of measurement: Less than 5 minutes fast, between 5-10 minutes medium and more than 10 minutes slow recovery. Comparison of hemodynamic changes in the two groups of midazolam-propofol with midazolam-ketamine in patients undergoing outpatient endoscopy. Timepoint: Vital signs (including heart rate, systolic and diastolic blood pressure, and oxygen saturation) before, and during, induction. Method of measurement: Heart rate per minute and systolic and diastolic blood pressure based on millimeters of mercury and arterial blood oxygen saturation. Age, sex and weight in patients in the two groups of midazolam - propofol with midazolam - ketamine in patients undergoing outpatient endoscopy. Timepoint: On arrival. Method of measurement: Age based on number of years of life and weight based on kg and sex based on phenotype. Ahvaz University of Medical Sciences Approved 2019-09-28 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz University City - Deputy of Research and Technology - Information Office Ahvaz Khouzestan Iran (Islamic Republic of)