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IRCT20201027049160N1 IRCT 2020-11-04 Ahvaz University of Medical Sciences Comparison of sedative efficacy of propofol-ketamine versus propofol-ketamin plus lidocaine spray outside the operating room Comparison of the sedative efficacy of propofol-ketamine combination versus propofol-ketamine plus lidocaine spray in outpatient endoscopy 2020-09-22 anticipated 154 Complete https://irct.ir/trial/51990 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The number of patients will be randomly divided into four groups based on the case number, Blinding description: In order to double blind the study, the patient's degree of sedation is recorded according to a modified Ramsay standard during the procedure by another person who does not know the medication prescribed to the patient. 2-3 Sedation management of patients referred for Endoscopy and reduce their anxiety. Intervention 1: Control group: The group receiving Propofol Ketamin for sedation during Endoscopy. Intervention 2: Intervention group: The group receiving Propofol Ketamin plus Lidocaine spray for sedation during Endoscopy. Yes - There is a plan to make this available What will be shared: The Excel file contains the identification code, reference to the file number and the registered information, except for the documents that can be provided. When: 6 months after printing the results until 10 years later To whom: All those who officially correspond with the Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences Conditions: Documents can be used for systematic review studies and meta-analysis Where to obtain: Vice Chancellor for Research Ahvaz Jundishapur University How to obtain: After approval from the Vice Chancellor for Research, the data file will be provided to the Vice Chancellor and then the data will be shared with other researchers or emailed to them. Comments:
public Reza Akhondzade
Unit 3,Second floors,Ferdos Building,NO.57,Second West Street,Phase One,Chamran Blvd,kianpars
Ahvaz Iran (Islamic Republic of) 6155819931 +98 61 3391 3455 Kiamohammadi.sh@ajums.ac.ir Ahvaz University of Medical Sciences scientific Reza Akhondzade
Unit 3,Second floors,Ferdos Building,NO.57,Second West Street,Phase One,Chamran Blvd,kianpars
Ahvaz Iran (Islamic Republic of) 6155819931 +98 61 3391 3455 Rezaakh@hotmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Candidate patients for endoscopy who require anesthesia In the age range of 18 to 65 years old Classification of Group 1 American Society of Anesthesiologists (ASA Class I) are selected as inclusion criteria 18 years 65 years Both the patient's unwillingness to participate in the study Age less than 18 years or more than 65 years They have cardiovascular disease They have kidney failure or liver failure They are addicted Contraindicated propofol ketamine or lidocaine spray Esophageal or gastric perforation during the procedure Esophageal or gastric bleeding during the procedure Changing the type of procedure during endoscopy or the need for surgery Treatment - Drugs Treatment - Drugs Control group: The group receiving Propofol Ketamin for sedation during Endoscopy. Intervention group: The group receiving Propofol Ketamin plus Lidocaine spray for sedation during Endoscopy. A score of 5 or 6 Ramsay criteria in the questionnaire. Ramsay sedation criteria including 6 scores is as follows: 1. Completely awake and anxious 2. Quiet and calm with enough cooperation 3. Asleep and wakes up with a verbal command 4. Asleep and woke up with mild stimulation, but gives a strong reaction to painful stimuli 5. Slow reaction to painful stimuli 6. Lack of reaction to painful stimulition. Timepoint: 5 minutes after the procedure, 10 minutes after the procedure, 15 minutes after the procedure. Method of measurement: Verbal measurement criteria. Recovery time. Timepoint: Recovery time is defined as fast (less than 5 minutes), medium (between 5 to 10 minutes) and slow (more than 15 minutes). Method of measurement: Patient's appropriate answers to questions. Nausa and vomiting of patients based on visual analogue score from the end of the procedure until the time of recovery will be recorded. Timepoint: Every 5 minutes. Method of measurement: It is expressed by the person herself/himself. Blood pressure. Timepoint: Every 5 minutes. Method of measurement: Blood pressure monitor. Heart beat. Timepoint: Every 5 minute. Method of measurement: Cardaic monitor. Arterial blood oxygen saturation. Timepoint: Every 5 minutes. Method of measurement: Respiratory monitor. Ahvaz University of Medical Sciences Approved 2020-06-07 کمیته اخلاق در پژوهش دانشگاه علوم پزشکی جندی شاپور اهواز Golestan Hospital, Golestan BLVD Ahvaz Khouzestan Iran (Islamic Republic of)